FDA product code · Unknown
FRODressing, Wound, Drug
Product code FRO covers Dressing, Wound, Drug, a Class U device. FDA has cleared 705 devices in this code, 18 of them in the last 12 months. Median review time across the 705 most recent decisions is 148 days. openFDA lists 82 recall records against this code.
Updated · ingest status · JSON
- Class
- Class U
- Regulation
- —
- Review panel
- Unknown
- Clearances
- 705
What is happening in FRO right now?
FRO (Dressing, Wound, Drug) has four findings, most consequential first. 5 recalls opened in the last 12 months and not yet terminated (Class II) (Z-2677-2026, Z-2275-2026, Z-1363-2026, Z-1364-2026, Z-1365-2026). 11 first-time filers in the last 12 months, including Silverceuticals, Inc. and Merit Medical Systems, Inc (K251929, K254073, K254191, K252023, K251999). Clearances are running 42% slower — a median 210 days over the last 12 months against 148 days all-time (elapsed calendar days, not FDA review days) (FRO:review_time:12m). The code is crowded, scoring 100 of 100 — 326 companies hold a clearance here and 18 arrived in the last 12 months (FRO:crowding).
| Finding | How much it matters | FDA records |
|---|---|---|
| Recall | Class II recall | Z-2677-2026, Z-2275-2026, Z-1363-2026, Z-1364-2026, Z-1365-2026 |
| New entrant | Worth knowing | K251929, K254073, K254191, K252023, K251999 |
| Review time | Context | FRO:review_time:12m |
| Crowding | Context | FRO: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 FRO?
FDA has cleared 705 devices under product code FRO since the 510(k) programme began in 1976, 18 of them in the last 12 months.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261023 | Microdacyn Wound Irrigation Solution | Sonoma Pharmaceuticals, Inc. | |
| K251929 | SilverCeuticals® Antimicrobial Wound Gel | Silverceuticals, Inc. | |
| K261638 | Bonvadis® | Oneness Biotech Co., Ltd. | |
| K254073 | StatSeal Disc | Merit Medical Systems, Inc. | |
| K254191 | IWD-Gel | InnovaCorium, Inc. | |
| K252023 | MiraChlor Antimicrobial Wound Solution | Letus Corporation | |
| K251999 | Promogran Prisma Collagen Matrix with ORC and Silver | Solventum Germany GmbH | |
| K252028 | LUOFUCON® Antimicrobial Wound Gel | Huizhou Foryou Medical Co., Ltd. | |
| K251582 | Redermax Antibacterial Wound Matrix | Beijing Kreate Medical Co., Ltd. | |
| K252568 | New Day Skin Spray | Silk Holdings, Inc. |
How long does FDA review take for FRO?
The median FDA review time for FRO is 148 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 FRO?
openFDA lists 82 recall records against product code FRO. A recall record covers one firm's corrective action and may span many device lots.
Z-2677-2026Open, ClassifiedConvatec Inc.
Surgical dressing manufactured out of specification (greater thickness).
Z-2275-2026Open, ClassifiedOculus Technologies of Mexico, S.A. de C.V.
The recall is being conducted due to corrosion of the internal metallic spring within the sprayer component. This condition is caused by material incompatibility between the product solution and the stainless steel spring and may result in visible discoloration and the presence of trace levels of metallic elements (including iron, chromium, and nickel) in the solution during use.
Z-1363-2026Open, ClassifiedIntegra LifeSciences Corp. (NeuroSciences)
Potential packaging failures, which could lead to a breach in the sterile barrier.
Z-1364-2026Open, ClassifiedIntegra LifeSciences Corp. (NeuroSciences)
Potential packaging failures, which could lead to a breach in the sterile barrier.
Z-1365-2026Open, ClassifiedIntegra LifeSciences Corp. (NeuroSciences)
Potential packaging failures, which could lead to a breach in the sterile barrier.
Showing the 5 most recently initiated of 82. 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 FRO?
MAUDE holds 586 adverse-event reports naming product code FRO, 124 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 FRO unusual?
Every month with enough history behind it falls inside FRO's own expected range. Nothing here is unusual for this code.
| Month | Reports | Expected | Verdict |
|---|---|---|---|
| 11 | Insufficient history | No expected range — too little history | |
| 5 | Insufficient history | No expected range — too little history | |
| 4 | Insufficient history | No expected range — too little history | |
| 15 | Insufficient history | No expected range — too little history | |
| 34 | Insufficient history | No expected range — too little history | |
| 20 | Insufficient history | No expected range — too little history | |
| 8 | Insufficient history | No expected range — too little history | |
| 4 | Insufficient history | No expected range — too little history | |
| 9 | Insufficient history | No expected range — too little history | |
| 34 | Insufficient history | No expected range — too little history | |
| 9 | Insufficient history | No expected range — too little history | |
| 10 | Insufficient history | No expected range — too little history | |
| 24 | Insufficient history | No expected range — too little history | |
| 15 | Insufficient history | No expected range — too little history | |
| 30 | Insufficient history | No expected range — too little history | |
| 31 | Insufficient history | No expected range — too little history | |
| 12 | Insufficient history | No expected range — too little history | |
| 12 | Insufficient history | No expected range — too little history | |
| 27 | Insufficient history | No expected range — too little history | |
| 16 | Insufficient history | No expected range — too little history | |
| 12 | Insufficient history | No expected range — too little history | |
| 18 | 0–34 | Within expected (0–34) | |
| 20 | 1–27 | Within expected (1–27) | |
| 29 | 3–32 | Within expected (3–32) | |
| 8 | 7–37 | Within expected (7–37) | |
| 16 | 1–32 | Within expected (1–32) | |
| 14 | 1–33 | Within expected (1–33) | |
| 8 | 4–47 | Within expected (4–47) | |
| 15 | 0–32 | Within expected (0–32) | |
| 22 | 0–33 | Within expected (0–33) | |
| 10 | 1–35 | Within expected (1–35) | |
| 19 | 0–29 | Within expected (0–29) | |
| 8 | 0–34 | Within expected (0–34) | |
| 4 | 0–37 | Within expected (0–37) | |
| 24 | 0–30 | Within expected (0–30) | |
| 23 | 0–36 | Within expected (0–36) |
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 FRO.
Who has entered FRO in the last year?
8 companies filed in FRO for the first time in the last 12 months.
| Company | First cleared | K-number |
|---|---|---|
| Silverceuticals, Inc. | K251929 | |
| Merit Medical Systems, Inc. | K254073 | |
| InnovaCorium, Inc. | K254191 | |
| Letus Corporation | K252023 | |
| Solventum Germany GmbH | K251999 | |
| Huizhou Foryou Medical Co., Ltd. | K252028 | |
| Beijing Kreate Medical Co., Ltd. | K251582 | |
| Silk Holdings, Inc. | K252568 |
"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 FRO?
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 FRO?
Across the 705 most recent decisions, these applicants filed most often in FRO.
| Applicant | Recent clearances |
|---|---|
| Huizhou Foryou Medical Devices Co., Ltd. | 16 |
| Convatec, A Division of E.R. Squibb & Sons | 13 |
| Derma Sciences, Inc. | 12 |
| Winner Medical Co., Ltd. | 12 |
| 3M Company | 10 |
Applicant names above are exactly as FDA published them, so one company can appear under several spellings.
The same makers, after name resolution
3 companies in FRO 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 |
|---|---|---|
| Convatec Inc. | 23 | 6 |
| Advanced Medical Solutions Limited | 19 | 2 |
| Oculus Innovative Sciences, Inc. | 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 FRO
Get an email the morning anything changes in FRO — a new clearance, a recall, or an adverse-event spike above this code's own baseline.
Related product codes in Unknown
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.