FDA product code · General Hospital
FMINeedle, Hypodermic, Single Lumen
Product code FMI covers Needle, Hypodermic, Single Lumen, a Class II device regulated under 21 CFR 880.5570. FDA has cleared 689 devices in this code, 9 of them in the last 12 months. Median review time across the 689 most recent decisions is 91 days. openFDA lists 308 recall records against this code.
Updated · ingest status · JSON
- Class
- Class II
- Regulation
- 21 CFR 880.5570
- Review panel
- General Hospital
- Clearances
- 689
What is happening in FMI right now?
FMI (Needle, Hypodermic, Single Lumen) has two findings, most consequential first. 2 first-time filers in the last 12 months, Hh Global Technology, Inc. and CMT Health PTE., Ltd (K252886, K252631). The code is crowded, scoring 88 of 100 — 375 companies hold a clearance here and 9 arrived in the last 12 months (FMI:crowding).
| Finding | How much it matters | FDA records |
|---|---|---|
| New entrant | Worth knowing | K252886, K252631 |
| Crowding | Context | FMI: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 FMI?
FDA has cleared 689 devices under product code FMI since the 510(k) programme began in 1976, 9 of them in the last 12 months.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260739 | Profoject Pen Needles (Model A; Model B) | CMT Health PTE., Ltd. | |
| K260855 | Profoject Safety Pen Needles | CMT Health PTE., Ltd. | |
| K254273 | Verisafe Safety Sterile Needles (SSN) | Promisemed Hangzhou Meditech Co., Ltd. | |
| K252908 | Easydrip Classic Pen Needle; Easydrip Plus Pen Needle; Easydrip Classic Pro Pen Needle; Easydrip Plus Pro Pen Needle | Sandstone Medical (Suzhou), Inc. | |
| K253047 | PRESSONE | Nipro Medical Corporation | |
| K253622 | Safety Pen Needle | Ningbo Medsun Medical Co., Ltd. | |
| K252886 | Pen Needle | Hh Global Technology, Inc. | |
| K250700 | Pen Injector Needle 32.5 | Terumo Corporation | |
| K252631 | Profoject Disposable Needle | CMT Health PTE., Ltd. | |
| K250724 | Intraosseous Infusion Needles | Spectrum Vascular |
How long does FDA review take for FMI?
The median FDA review time for FMI is 91 days, measured across the 689 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 FMI?
openFDA lists 308 recall records against product code FMI. A recall record covers one firm's corrective action and may span many device lots.
Z-2118-2025Open, ClassifiedWaismed Ltd.
Due to manufacturing error, Intraosseous device built-in stabilizer may not be released properly after deployment and insertion.
Z-2119-2025Open, ClassifiedWaismed Ltd.
Due to manufacturing error, Intraosseous device built-in stabilizer may not be released properly after deployment and insertion.
Z-0802-2025Open, ClassifiedGreiner Bio-One GmbH
The VACUETTE SAFELINK Holder with male luer lock may leak blood due to the protective rubber sleeve bunching up and not retracting when using the device.
Z-2424-2024Open, ClassifiedEmbecta Corp.
BD Nano 2nd Gen Pen Needle was shipped close to or after the labeled expiration date of February 29, 2024. Using a device past its expiry sterility and integrity of the device cannot be guaranteed.
Z-1293-2024Open, ClassifiedRetractable Technologies, Inc.
The needle cannula of a retractable needle may detach from the needle holder in the patient.
Showing the 5 most recently initiated of 308. 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 FMI?
MAUDE holds 10,712 adverse-event reports naming product code FMI, 1,156 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 FMI unusual?
Every month with enough history behind it falls inside FMI's own expected range. Nothing here is unusual for this code.
| Month | Reports | Expected | Verdict |
|---|---|---|---|
| 315 | Insufficient history | No expected range — too little history | |
| 322 | Insufficient history | No expected range — too little history | |
| 547 | Insufficient history | No expected range — too little history | |
| 387 | Insufficient history | No expected range — too little history | |
| 454 | Insufficient history | No expected range — too little history | |
| 485 | Insufficient history | No expected range — too little history | |
| 359 | Insufficient history | No expected range — too little history | |
| 496 | Insufficient history | No expected range — too little history | |
| 362 | Insufficient history | No expected range — too little history | |
| 400 | Insufficient history | No expected range — too little history | |
| 337 | Insufficient history | No expected range — too little history | |
| 287 | Insufficient history | No expected range — too little history | |
| 310 | Insufficient history | No expected range — too little history | |
| 329 | Insufficient history | No expected range — too little history | |
| 276 | Insufficient history | No expected range — too little history | |
| 300 | Insufficient history | No expected range — too little history | |
| 305 | Insufficient history | No expected range — too little history | |
| 316 | Insufficient history | No expected range — too little history | |
| 382 | Insufficient history | No expected range — too little history | |
| 391 | Insufficient history | No expected range — too little history | |
| 420 | Insufficient history | No expected range — too little history | |
| 232 | 257–417 | Below expected (257–417) | |
| 228 | 194–337 | Within expected (194–337) | |
| 236 | 203–365 | Within expected (203–365) | |
| 218 | 188–370 | Within expected (188–370) | |
| 300 | 150–338 | Within expected (150–338) | |
| 198 | 172–369 | Within expected (172–369) | |
| 152 | 218–563 | Below expected (218–563) | |
| 166 | 62–420 | Within expected (62–420) | |
| 173 | 23–438 | Within expected (23–438) | |
| 153 | 0–431 | Within expected (0–431) | |
| 137 | 0–376 | Within expected (0–376) | |
| 174 | 0–388 | Within expected (0–388) | |
| 143 | 15–394 | Within expected (15–394) | |
| 109 | 0–324 | Within expected (0–324) | |
| 145 | 0–335 | Within expected (0–335) |
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 FMI.
Who has entered FMI in the last year?
2 companies filed in FMI for the first time in the last 12 months.
| Company | First cleared | K-number |
|---|---|---|
| Hh Global Technology, Inc. | K252886 | |
| CMT Health PTE., Ltd. | K252631 |
"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 FMI?
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 FMI?
Across the 689 most recent decisions, these applicants filed most often in FMI.
| Applicant | Recent clearances |
|---|---|
| Bd Becton Dickinson Vacutainer Systems Preanalytic | 20 |
| Terumo Europe N.V. | 15 |
| Sherwood Medical Co. | 13 |
| Vidacare Corporation | 13 |
| Promisemed Hangzhou Meditech Co., Ltd. | 12 |
Applicant names above are exactly as FDA published them, so one company can appear under several spellings.
The same makers, after name resolution
2 companies in FMI 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 |
|---|---|---|
| Becton, Dickinson and Company | 22 | 3 |
| Vidacare Corporation | 14 | 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 FMI
Get an email the morning anything changes in FMI — 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.