FDA product code · Cardiovascular
DYBIntroducer, Catheter
Product code DYB covers Introducer, Catheter, a Class II device regulated under 21 CFR 870.1340. FDA has cleared 705 devices in this code, 24 of them in the last 12 months. Median review time across the 705 most recent decisions is 87 days. openFDA lists 388 recall records against this code.
Updated · ingest status · JSON
- Class
- Class II
- Regulation
- 21 CFR 870.1340
- Review panel
- Cardiovascular
- Clearances
- 705
What is happening in DYB right now?
DYB (Introducer, Catheter) has five findings, most consequential first. 5 recalls opened in the last 12 months and not yet terminated (Class I) (Z-2681-2026, Z-2682-2026, Z-2683-2026, Z-2684-2026, Z-2685-2026). Adverse events reported in 2026-03 ran high — 678 reports against an expected 318 to 634 (DYB:MAUDE:2026-03). 13 first-time filers in the last 12 months, including Hartman Medical Group, LLC and Pendracare (K261529, K261242, K261950, K260606, K260091). Clearances are running 36% faster — a median 56 days over the last 12 months against 87 days all-time (elapsed calendar days, not FDA review days) (DYB:review_time:12m). The code is crowded, scoring 100 of 100 — 244 companies hold a clearance here and 24 arrived in the last 12 months (DYB:crowding).
| Finding | How much it matters | FDA records |
|---|---|---|
| Recall | Class I recall | Z-2681-2026, Z-2682-2026, Z-2683-2026, Z-2684-2026, Z-2685-2026 |
| Adverse-event spike | Serious | DYB:MAUDE:2026-03 |
| New entrant | Worth knowing | K261529, K261242, K261950, K260606, K260091 |
| Review time | Context | DYB:review_time:12m |
| Crowding | Context | DYB:crowding |
Sources checked: predicate ancestry, recalls, adverse events, new entrants, review time, crowding. Composed . Every finding carries the record ids it was derived from; nothing here is an estimate.
How many devices has FDA cleared in DYB?
FDA has cleared 705 devices under product code DYB since the 510(k) programme began in 1976, 24 of them in the last 12 months.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261529 | Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set/ Microintroducer Kit / Microintroducer Kit (SIS05C); Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set / Microintroducer Kit / Microintroducer Kit (IS01); Introducer Kit / Microintroducer Kit / Introducer Set /Microintroducer Set / Micro Introducer Sheath Set / Introducer Sheath Set (NIS04) | Hartman Medical Group, LLC | |
| K261242 | SimplGuide | Pendracare | |
| K261950 | Health Line Tearaway Introducer | Health Line International Corporation | |
| K261492 | FieldFlex Steerable Sheath | CenterPoint Systems, LLC | |
| K260606 | Echo Large Bore Introducer Sheath | Echo Medical, LLC | |
| K254248 | Introducer Sheath Set | Cardiocycle Medical(Suzhou) Co., Ltd. | |
| K254279 | Edwards eSheath+ introducer set | Edwards Lifesciences | |
| K260091 | Aventus Introducer Sheath | Inquis Medical | |
| K260839 | Protaryx Transseptal Puncture Device (PTX2-001) | Protaryx Medical, Inc. | |
| K260942 | AuST Steerable Sheath | CenterPoint Systems, LLC |
How long does FDA review take for DYB?
The median FDA review time for DYB is 87 days, measured across the 705 most recent decisions with both a received date and a decision date.
Review time here is decision date minus date received, as published by FDA. It is elapsed calendar time, not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Are there recalls in DYB?
openFDA lists 388 recall records against product code DYB. A recall record covers one firm's corrective action and may span many device lots.
Z-2681-2026Open, ClassifiedAbiomed, Inc.
A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set.
Z-2682-2026Open, ClassifiedAbiomed, Inc.
A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set.
Z-2683-2026Open, ClassifiedAbiomed, Inc.
A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set.
Z-2684-2026Open, ClassifiedAbiomed, Inc.
A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set.
Z-2685-2026Open, ClassifiedAbiomed, Inc.
A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set.
Showing the 5 most recently initiated of 388. Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Status is FDA's own wording; a terminated recall is a closed one, and the total spans the code's whole history, not just what is open today.
Source: openFDA device/recall · retrieved
How many adverse events are reported for DYB?
MAUDE holds 12,815 adverse-event reports naming product code DYB, 3,634 of them received in the last 12 months.
MAUDE reports are submitted by manufacturers, importers, user facilities and the public. They are unverified, and a report is not proof that the device caused the event.
Source: openFDA device/event · retrieved
Is adverse-event reporting in DYB unusual?
3 months sit above DYB's own expected range: 1 May 2025, 1 June 2025, 1 March 2026.
| Month | Reports | Expected | Verdict |
|---|---|---|---|
| 226 | Insufficient history | No expected range — too little history | |
| 289 | Insufficient history | No expected range — too little history | |
| 402 | Insufficient history | No expected range — too little history | |
| 275 | Insufficient history | No expected range — too little history | |
| 286 | Insufficient history | No expected range — too little history | |
| 340 | Insufficient history | No expected range — too little history | |
| 233 | Insufficient history | No expected range — too little history | |
| 416 | Insufficient history | No expected range — too little history | |
| 254 | Insufficient history | No expected range — too little history | |
| 275 | Insufficient history | No expected range — too little history | |
| 282 | Insufficient history | No expected range — too little history | |
| 354 | Insufficient history | No expected range — too little history | |
| 335 | Insufficient history | No expected range — too little history | |
| 323 | Insufficient history | No expected range — too little history | |
| 347 | Insufficient history | No expected range — too little history | |
| 382 | Insufficient history | No expected range — too little history | |
| 340 | Insufficient history | No expected range — too little history | |
| 270 | Insufficient history | No expected range — too little history | |
| 317 | Insufficient history | No expected range — too little history | |
| 319 | Insufficient history | No expected range — too little history | |
| 387 | Insufficient history | No expected range — too little history | |
| 292 | 231–386 | Within expected (231–386) | |
| 251 | 200–329 | Within expected (200–329) | |
| 318 | 222–363 | Within expected (222–363) | |
| 310 | 243–378 | Within expected (243–378) | |
| 358 | 230–351 | Above expected (230–351) | |
| 414 | 248–397 | Above expected (248–397) | |
| 348 | 404–696 | Below expected (404–696) | |
| 382 | 244–495 | Within expected (244–495) | |
| 385 | 259–524 | Within expected (259–524) | |
| 462 | 264–511 | Within expected (264–511) | |
| 398 | 256–483 | Within expected (256–483) | |
| 545 | 294–546 | Within expected (294–546) | |
| 421 | 353–701 | Within expected (353–701) | |
| 468 | 273–564 | Within expected (273–564) | |
| 678 | 318–634 | Above expected (318–634) |
21 months do not have a full, unbroken year of history before them, so no expected range is shown for those. Insufficient history is reported as insufficient rather than as zero: an empty baseline would turn a gap in our data into a spike. Method: ewma_alpha_0.3_sd_2 corpus_adjusted. Counts are divided by the corpus-wide volume for that month before comparison, so a rise across all of MAUDE is not reported as a rise in DYB.
Who has entered DYB in the last year?
8 companies filed in DYB for the first time in the last 12 months.
| Company | First cleared | K-number |
|---|---|---|
| Hartman Medical Group, LLC | K261529 | |
| Pendracare | K261242 | |
| Health Line International Corporation | K261950 | |
| Echo Medical, LLC | K260606 | |
| INQUIS MEDICAL, INC. | K260091 | |
| Protaryx Medical, Inc. | K260839 | |
| Zoll Respicardia, Inc. | K260459 | |
| VascuTech Medical, LLC | K254236 |
"First time" means their first clearance in this product code, not their first ever — an established manufacturer entering a new category is exactly the movement worth knowing about.
Source: openFDA device/510k · retrieved
What are the predicate devices in DYB?
FDA publishes no machine-readable predicate field, so no predicate chain is recorded for this code yet.
A predicate chain matters because a device inherits the safety history of what it was compared to. FDA publishes the chain only inside each 510(k) summary PDF, never as data — so where we have edges, they are read from those documents, and where we do not, we say so instead of showing an empty list.
Who files 510(k)s in DYB?
Across the 705 most recent decisions, these applicants filed most often in DYB.
| Applicant | Recent clearances |
|---|---|
| St Jude Medical | 21 |
| Cordis Corp. | 19 |
| Terumo Medical Corp. | 19 |
| Daig Corp. | 18 |
| Merit Medical Systems, Inc. | 18 |
Applicant names above are exactly as FDA published them, so one company can appear under several spellings.
The same makers, after name resolution
5 companies in DYB file under more than one spelling. Resolving them to one identity — across all six datasets, not just this one — is what makes a joined count possible at all.
| Company | Clearances | FDA spellings merged |
|---|---|---|
| Terumo Medical Corporation | 27 | 2 |
| St. Jude Medical, Inc. | 26 | 2 |
| Cordis Corporation | 22 | 2 |
| Cook Incorporated | 20 | 2 |
| Merit Medical Systems, Inc. | 19 | 2 |
Merges are measured against a hand-labelled sample and held above 98% precision; pairs the matcher is unsure of are queued for a person rather than merged. See DeviceSignal.
Source: openFDA device/510k · retrieved
Watch DYB
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Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.