FDA product code · General Hospital
FMFSyringe, Piston
Product code FMF covers Syringe, Piston, a Class II device regulated under 21 CFR 880.5860. FDA has cleared 749 devices in this code, 13 of them in the last 12 months. Median review time across the 749 most recent decisions is 87 days. openFDA lists 305 recall records against this code.
Updated · ingest status · JSON
- Class
- Class II
- Regulation
- 21 CFR 880.5860
- Review panel
- General Hospital
- Clearances
- 749
What is happening in FMF right now?
FMF (Syringe, Piston) has four findings, most consequential first. 4 recalls opened in the last 12 months and not yet terminated (Class I, Class II) (Z-2614-2026, Z-2396-2026, Z-1768-2026, Z-1496-2026). 5 first-time filers in the last 12 months, including embecta Medical II, LLC and CHIRANA T.INJECTA, A.S (K260208, K252279, K252518, K251089, K243660). Clearances are running 171% slower — a median 236 days over the last 12 months against 87 days all-time (elapsed calendar days, not FDA review days) (FMF:review_time:12m). The code is crowded, scoring 97 of 100 — 436 companies hold a clearance here and 13 arrived in the last 12 months (FMF:crowding).
| Finding | How much it matters | FDA records |
|---|---|---|
| Recall | Class I recall | Z-2614-2026, Z-2396-2026, Z-1768-2026, Z-1496-2026 |
| New entrant | Worth knowing | K260208, K252279, K252518, K251089, K243660 |
| Review time | Context | FMF:review_time:12m |
| Crowding | Context | FMF: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 FMF?
FDA has cleared 749 devices under product code FMF since the 510(k) programme began in 1976, 13 of them in the last 12 months.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260208 | Ultra-Fine SAFETY Insulin Syringe | embecta Medical II, LLC | |
| K253110 | Sol-Glide Safety Needle; Sol-Glide Safety Needle with Syringe | Sol-Millennium Medical, Inc. | |
| K260514 | Profoject Safety Needle; Profoject Syringe with Safety Needle; Profoject Low Dead Space Syringe with Safety Needle | CMT Health PTE., Ltd. | |
| K253112 | Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec (Membrane Filter Syringe) | Hlb Lifescience Co., Ltd. | |
| K252279 | Sterile Hypodermic Syringe for Single Use (20ml, 30ml, 50ml, 60ml) | Chirana T.Injecta,A.S. | |
| K253068 | Profoject Insulin Syringes; Profoject Safelock Disposable Insulin Syringe | CMT Health PTE., Ltd. | |
| K253769 | Instylla Delivery Kit | Instylla, Inc. | |
| K252518 | DuoprossTM Smart Cap (Type I) | Duopross Meditech Corporate | |
| K251089 | EXEL Disposable Syringe; EXEL Disposable Syringe with Needle; EXEL Disposable Syringe with Secure Touch® Safety Needle; EXEL Disposable Hypodermic Needle | Exelint International, Co. | |
| K250192 | Verisafe Safety Retractable Insulin Syringes | Promisemed Hangzhou Meditech Co., Ltd. |
How long does FDA review take for FMF?
The median FDA review time for FMF is 87 days, measured across the 749 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 FMF?
openFDA lists 305 recall records against product code FMF. A recall record covers one firm's corrective action and may span many device lots.
Z-2614-2026Open, ClassifiedMentor Texas LP
A single lot of expired syringes were distributed due to a distribution system control failure.
Z-2396-2026Open, ClassifiedArrow International, Inc., Division of Teleflex Medical Inc.
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
Z-1768-2026Open, ClassifiedCardinal Health 200, LLC
The outer packaging and blister pack labeling identify the product as 1mL Luer Lock Tuberculin Syringe (Product Code 1180100777), however the syringes contained within the packages are U-100 Insulin syringes.
Z-1496-2026Open, ClassifiedBecton, Dickinson and Company
During the bulk packaging process, some Luer Slip syringes were incorrectly included in a batch designated for Luer Lok syringes.
Z-1961-2025Open, ClassifiedIntegra LifeSciences Corp. (NeuroSciences)
Lack of sterility assurance.
Showing the 5 most recently initiated of 305. 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 FMF?
MAUDE holds 14,327 adverse-event reports naming product code FMF, 2,700 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 FMF unusual?
Every month with enough history behind it falls inside FMF's own expected range. Nothing here is unusual for this code.
| Month | Reports | Expected | Verdict |
|---|---|---|---|
| 690 | Insufficient history | No expected range — too little history | |
| 302 | Insufficient history | No expected range — too little history | |
| 513 | Insufficient history | No expected range — too little history | |
| 386 | Insufficient history | No expected range — too little history | |
| 387 | Insufficient history | No expected range — too little history | |
| 442 | Insufficient history | No expected range — too little history | |
| 318 | Insufficient history | No expected range — too little history | |
| 473 | Insufficient history | No expected range — too little history | |
| 385 | Insufficient history | No expected range — too little history | |
| 493 | Insufficient history | No expected range — too little history | |
| 432 | Insufficient history | No expected range — too little history | |
| 459 | Insufficient history | No expected range — too little history | |
| 552 | Insufficient history | No expected range — too little history | |
| 496 | Insufficient history | No expected range — too little history | |
| 354 | Insufficient history | No expected range — too little history | |
| 483 | Insufficient history | No expected range — too little history | |
| 360 | Insufficient history | No expected range — too little history | |
| 371 | Insufficient history | No expected range — too little history | |
| 349 | Insufficient history | No expected range — too little history | |
| 352 | Insufficient history | No expected range — too little history | |
| 421 | Insufficient history | No expected range — too little history | |
| 314 | 201–516 | Within expected (201–516) | |
| 262 | 162–438 | Within expected (162–438) | |
| 281 | 162–484 | Within expected (162–484) | |
| 407 | 157–488 | Within expected (157–488) | |
| 387 | 219–430 | Within expected (219–430) | |
| 366 | 262–448 | Within expected (262–448) | |
| 306 | 419–710 | Below expected (419–710) | |
| 365 | 231–502 | Within expected (231–502) | |
| 413 | 243–528 | Within expected (243–528) | |
| 364 | 249–532 | Within expected (249–532) | |
| 317 | 217–473 | Within expected (217–473) | |
| 335 | 230–518 | Within expected (230–518) | |
| 334 | 253–581 | Within expected (253–581) | |
| 349 | 182–480 | Within expected (182–480) | |
| 354 | 205–532 | Within expected (205–532) |
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 FMF.
Who has entered FMF in the last year?
5 companies filed in FMF for the first time in the last 12 months.
| Company | First cleared | K-number |
|---|---|---|
| embecta Medical II, LLC | K260208 | |
| CHIRANA T.INJECTA, A.S. | K252279 | |
| Duopross Meditech Corporate | K252518 | |
| Exelint International, Co. | K251089 | |
| Cardinalhealth | K243660 |
"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 FMF?
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 FMF?
Across the 749 most recent decisions, these applicants filed most often in FMF.
| Applicant | Recent clearances |
|---|---|
| Bd Becton Dickinson Vacutainer Systems Preanalytic | 23 |
| Sherwood Medical Co. | 20 |
| Becton, Dickinson and Company | 13 |
| Merit Medical Systems, Inc. | 10 |
| Terumo Medical Corp. | 10 |
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 FMF 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 |
|---|---|---|
| Becton, Dickinson and Company | 18 | 4 |
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 FMF
Get an email the morning anything changes in FMF — 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.