Acacia Laboratories, Inc.: FDA filings under this applicant name
FDA lists 12 510(k) clearances under the applicant name “Acacia Laboratories, Inc.” (first 1988, latest 1995), across 9 product codes in 4 review panels. Median 510(k) review time under this name: 53 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KMF | Bandage, Liquid | 2 | 2 |
| LYV | Label Or Tag, Sterile | 2 | 2 |
| MGQ | Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic | 2 | 2 |
| BYY | Tube, Aspirating, Flexible, Connecting | 1 | 1 |
| DWS | Instruments, Surgical, Cardiovascular | 1 | 1 |
| FCM | Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit) | 1 | 1 |
| KKX | Drape, Surgical, Antimicrobial | 1 | 1 |
| KNY | Accessories, Catheter, G-U | 1 | 1 |
| KRI | Accessory Equipment, Cardiopulmonary Bypass | 1 | 1 |
Review panels
- General and Plastic Surgery (6)
- Cardiovascular (2)
- Gastroenterology and Urology (2)
- General Hospital (2)
Most recent Acacia Laboratories, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K952419 | STERIGAUZE GEL DRESSING | MGQ | 1995-07-26 | 64 |
| K952420 | STERIGAUZE WET DRESSING | KMF | 1995-07-12 | 50 |
| K951861 | STERICARE WOUND CARE GEL | MGQ | 1995-07-11 | 81 |
| K952414 | PREFILLED SYRINGE FOR INFLATION OF FOLEY CATHETER | KNY | 1995-06-23 | 31 |
| K951914 | HYDRACARE ABSORBENT WOUND DRESSING | KMF | 1995-05-15 | 21 |
| K950344 | HORIZON FOLEY CATHETERIZATION TRAY WITHOUT CATHETER | FCM | 1995-03-24 | 56 |
| K913408 | STERILE PLASTIC DRAPE | KKX | 1992-03-12 | 226 |
| K901761 | STERILE SUCTION TUBING SET | BYY | 1990-05-07 | 19 |
| K892856 | NEWMARK(TM) CORONARY ARTERY BYPASS GRAFT MARKERS | KRI | 1989-11-08 | 204 |
| K892804 | NEWCHILL(TM) CARDIAC INSULATOR | DWS | 1989-07-14 | 88 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Acacia Laboratories, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Acacia, Inc. (17 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Acacia Laboratories, Inc.?
FDA lists 12 510(k) clearances under the applicant name “Acacia Laboratories, Inc.” (first 1988, latest 1995), across 9 product codes in 4 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Acacia Laboratories, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Acacia Laboratories, Inc. is 53 days.
Which FDA product codes appear under Acacia Laboratories, Inc.?
The most frequent FDA product codes under this applicant name are KMF (Bandage, Liquid, 2); LYV (Label Or Tag, Sterile, 2); MGQ (Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic, 2).
Next steps
- See all 12 Acacia Laboratories, Inc. clearances with predicates and recalls
- Run predicate analysis for product code KMF, Acacia Laboratories, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.