FDA product code · General Hospital
FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Product code FOZ covers Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days, a Class II device regulated under 21 CFR 880.5200. FDA has cleared 506 devices in this code, 8 of them in the last 12 months. Median review time across the 506 most recent decisions is 101 days. openFDA lists 394 recall records against this code.
Updated · ingest status · JSON
- Class
- Class II
- Regulation
- 21 CFR 880.5200
- Review panel
- General Hospital
- Clearances
- 506
What is happening in FOZ right now?
FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days) has three findings, most consequential first. 5 recalls opened in the last 12 months and not yet terminated (Class II) (Z-1914-2026, Z-1783-2026, Z-1788-2026, Z-1789-2026, Z-1407-2026). 1 first-time filer in the last 12 months, Terumo Medical Products (Hangzhou) Co., Ltd (K252398). The code is crowded, scoring 83 of 100 — 211 companies hold a clearance here and 8 arrived in the last 12 months (FOZ:crowding).
| Finding | How much it matters | FDA records |
|---|---|---|
| Recall | Class II recall | Z-1914-2026, Z-1783-2026, Z-1788-2026, Z-1789-2026, Z-1407-2026 |
| New entrant | Worth knowing | K252398 |
| Crowding | Context | FOZ: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 FOZ?
FDA has cleared 506 devices under product code FOZ since the 510(k) programme began in 1976, 8 of them in the last 12 months.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261041 | ClearSafe Closed System | MedSource Labs, LLC | |
| K260539 | MedSource QuickSafe Safety IV Catheter; MedSource PurSafe Safety IV Catheter | MedSource Labs, LLC | |
| K253235 | Introcan Safety® Deep Access XL IV Catheter | B.Braun Medical, Inc. | |
| K252137 | BD Insyte IV Catheter | Becton Dickinson Infusion Therapy Systems, Inc. | |
| K252513 | Polywin Safety (14G x 51mm; 16G x 51mm; 18G x 64mm; 20G x 64mm; 20G x 45mm; 22G x 64mm; 22G x 45mm; 24G x 32mm; 24G x 14mm, 26G x 14mm); Polywin Safety Adva (20G x 45mm; 22G x 64mm; 22G x 45mm ; 24G x 32 mm; 24G x 14mm; 14G x 51mm; 16G x 51mm; 18G x 64mm; 20G x 64mm, 26G x 14mm) | Poly Medicure Limited | |
| K252398 | SURFLO Hybria Closed System Safety IV Catheter | Terumo Medical Products (Hangzhou) Co., Ltd. | |
| K252677 | Polyshield Safety IV Catheters | Poly Medicure Limited | |
| K251422 | BD Saf-T-Intima Subcutaneous Catheter System | Becton Dickinson Infusion Therapy Systems, Inc. | |
| K243403 | BD Nexiva Closed IV Catheter System | Becton Dickinson Infusion Therapy Systems, Inc. | |
| K251155 | BD Cathena Safety IV Catheter | Becton Dickinson Infusion Therapy Systems, Inc. |
How long does FDA review take for FOZ?
The median FDA review time for FOZ is 101 days, measured across the 506 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 FOZ?
openFDA lists 394 recall records against product code FOZ. A recall record covers one firm's corrective action and may span many device lots.
Z-1914-2026Open, ClassifiedArrow International, Inc., Division of Teleflex Medical Inc.
Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured
Z-1783-2026Open, ClassifiedCook Incorporated
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Z-1788-2026Open, ClassifiedCook Incorporated
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Z-1789-2026Open, ClassifiedCook Incorporated
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Z-1407-2026Open, ClassifiedMedline Industries, LP
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Showing the 5 most recently initiated of 394. 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 FOZ?
MAUDE holds 14,406 adverse-event reports naming product code FOZ, 3,098 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 FOZ unusual?
One month sits above FOZ's own expected range: 1 February 2025.
| Month | Reports | Expected | Verdict |
|---|---|---|---|
| 295 | Insufficient history | No expected range — too little history | |
| 255 | Insufficient history | No expected range — too little history | |
| 495 | Insufficient history | No expected range — too little history | |
| 309 | Insufficient history | No expected range — too little history | |
| 364 | Insufficient history | No expected range — too little history | |
| 426 | Insufficient history | No expected range — too little history | |
| 299 | Insufficient history | No expected range — too little history | |
| 436 | Insufficient history | No expected range — too little history | |
| 382 | Insufficient history | No expected range — too little history | |
| 308 | Insufficient history | No expected range — too little history | |
| 332 | Insufficient history | No expected range — too little history | |
| 335 | Insufficient history | No expected range — too little history | |
| 330 | Insufficient history | No expected range — too little history | |
| 428 | Insufficient history | No expected range — too little history | |
| 435 | Insufficient history | No expected range — too little history | |
| 427 | Insufficient history | No expected range — too little history | |
| 427 | Insufficient history | No expected range — too little history | |
| 349 | Insufficient history | No expected range — too little history | |
| 460 | Insufficient history | No expected range — too little history | |
| 486 | Insufficient history | No expected range — too little history | |
| 457 | Insufficient history | No expected range — too little history | |
| 350 | 298–501 | Within expected (298–501) | |
| 425 | 256–415 | Above expected (256–415) | |
| 438 | 304–507 | Within expected (304–507) | |
| 477 | 325–533 | Within expected (325–533) | |
| 452 | 320–514 | Within expected (320–514) | |
| 454 | 337–550 | Within expected (337–550) | |
| 407 | 532–870 | Below expected (532–870) | |
| 407 | 300–626 | Within expected (300–626) | |
| 425 | 293–645 | Within expected (293–645) | |
| 392 | 284–623 | Within expected (284–623) | |
| 433 | 231–556 | Within expected (231–556) | |
| 347 | 271–625 | Within expected (271–625) | |
| 436 | 258–704 | Within expected (258–704) | |
| 380 | 203–592 | Within expected (203–592) | |
| 394 | 229–630 | Within expected (229–630) |
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 FOZ.
Who has entered FOZ in the last year?
One company filed in FOZ for the first time in the last 12 months.
| Company | First cleared | K-number |
|---|---|---|
| Terumo Medical Products (Hangzhou) Co., Ltd. | K252398 |
"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 FOZ?
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 FOZ?
Across the 506 most recent decisions, these applicants filed most often in FOZ.
| Applicant | Recent clearances |
|---|---|
| Becton Dickinson Infusion Therapy Systems, Inc. | 30 |
| Menlo Care, Inc. | 22 |
| Parke-Davis Co. | 14 |
| B.Braun Medical, Inc. | 12 |
| Becton Dickinson Vascular Access, Inc. | 11 |
Applicant names above are exactly as FDA published them, so one company can appear under several spellings.
The same makers, after name resolution
One company in FOZ files 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 |
|---|---|---|
| Cook Incorporated | 13 | 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 FOZ
Get an email the morning anything changes in FOZ — a new clearance, a recall, or an adverse-event spike above this code's own baseline.
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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.