FDA product code · Unknown
KGNWound Dressing With Animal-Derived Material(S)
Product code KGN covers Wound Dressing With Animal-Derived Material(S), a Class U device. FDA has cleared 190 devices in this code, 17 of them in the last 12 months. Median review time across the 190 most recent decisions is 119 days. openFDA lists 23 recall records against this code.
Updated · ingest status · JSON
- Class
- Class U
- Regulation
- —
- Review panel
- Unknown
- Clearances
- 190
What is happening in KGN right now?
KGN (Wound Dressing With Animal-Derived Material(S)) has three findings, most consequential first. 5 recalls opened in the last 12 months and not yet terminated (Class II) (Z-1816-2026, Z-1817-2026, Z-1818-2026, Z-1819-2026, Z-1820-2026). 7 first-time filers in the last 12 months, including Ventris Medical and Ecm Therapeutics, Inc (K260596, K253521, K253204, K253974, K260218). The code is crowded, scoring 91 of 100 — 90 companies hold a clearance here and 17 arrived in the last 12 months (KGN:crowding).
| Finding | How much it matters | FDA records |
|---|---|---|
| Recall | Class II recall | Z-1816-2026, Z-1817-2026, Z-1818-2026, Z-1819-2026, Z-1820-2026 |
| New entrant | Worth knowing | K260596, K253521, K253204, K253974, K260218 |
| Crowding | Context | KGN: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 KGN?
FDA has cleared 190 devices under product code KGN since the 510(k) programme began in 1976, 17 of them in the last 12 months.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260596 | Collagen Wound Powder | Ventris Medical | |
| K260669 | Endoform Dermal Template | Aroa Biosurgery , Ltd. | |
| K253521 | ECMT-100 WMD | Ecm Therapeutics, Inc. | |
| K253204 | Catalyze | BioTissue Holdings, Inc. | |
| K254034 | Roosin Collagen Powder | Roosin Medical Co., Ltd. | |
| K253974 | Roosin Collagen Dressing | Roosin Medical Co., Ltd. | |
| K261224 | MatriDerm | Medskin Solutions Dr. Suwelack AG | |
| K260532 | Derma-Gide | Geistlich Pharma AG | |
| K260218 | LacertaMatrix | Lacerta Life Sciences | |
| K253140 | CollOvine Wound Powder | Ovigenex, LLC |
How long does FDA review take for KGN?
The median FDA review time for KGN is 119 days, measured across the 190 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 KGN?
openFDA lists 23 recall records against product code KGN. A recall record covers one firm's corrective action and may span many device lots.
Z-1816-2026Open, ClassifiedIntegra LifeSciences Corp. (NeuroSciences)
Increased rate of out-of-specification endotoxin results.
Z-1817-2026Open, ClassifiedIntegra LifeSciences Corp. (NeuroSciences)
Increased rate of out-of-specification endotoxin results.
Z-1818-2026Open, ClassifiedIntegra LifeSciences Corp. (NeuroSciences)
Increased rate of out-of-specification endotoxin results.
Z-1819-2026Open, ClassifiedIntegra LifeSciences Corp. (NeuroSciences)
Increased rate of out-of-specification endotoxin results.
Z-1820-2026Open, ClassifiedIntegra LifeSciences Corp. (NeuroSciences)
Increased rate of out-of-specification endotoxin results.
Showing the 5 most recently initiated of 23. 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 KGN?
MAUDE holds 37 adverse-event reports naming product code KGN, 8 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 KGN unusual?
KGN does not yet have twelve months of adverse-event history in our data, so there is no expected range to compare against. That is a gap in what we hold, not a statement about the device.
| Month | Reports | Expected | Verdict |
|---|---|---|---|
| 2 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 9 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history |
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.
Who has entered KGN in the last year?
7 companies filed in KGN for the first time in the last 12 months.
| Company | First cleared | K-number |
|---|---|---|
| Ventris Medical | K260596 | |
| Ecm Therapeutics, Inc. | K253521 | |
| BioTissue Holdings, Inc. | K253204 | |
| Roosin Medical Co., Ltd. | K253974 | |
| Lacerta Life Sciences | K260218 | |
| Lacerta Life Science | K252673 | |
| Helios Biomedical, Inc. | K250397 |
"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 KGN?
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 KGN?
Across the 190 most recent decisions, these applicants filed most often in KGN.
| Applicant | Recent clearances |
|---|---|
| Acell, Inc. | 13 |
| Collagen Matrix, Inc. | 8 |
| Innocoll Pharmaceuticals | 6 |
| Geistlich Pharma AG | 5 |
| Integra Lifesciences Corp. | 5 |
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 KGN 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 |
|---|---|---|
| Innocoll Pharmaceuticals, Ltd. | 8 | 2 |
| Integra LifeSciences Corporation | 7 | 2 |
| Cook Biotech, Inc. | 6 | 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 KGN
Get an email the morning anything changes in KGN — 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.