Acacia, Inc.: FDA filings under this applicant name
FDA lists 17 510(k) clearances under the applicant name “Acacia, Inc.” (first 1979, latest 2014), across 9 product codes in 2 review panels. Median 510(k) review time under this name: 100 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 | 1 | 241 |
| 2013 | 1 | 304 |
| 2014 | 1 | 11 |
| 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 |
|---|---|---|---|
| LHI | Set, I.V. Fluid Transfer | 5 | 5 |
| FMF | Syringe, Piston | 4 | 4 |
| FPA | Set, Administration, Intravascular | 2 | 2 |
| FMI | Needle, Hypodermic, Single Lumen | 1 | 1 |
| JTB | Device, Media Dispensing/Stacking | 1 | 1 |
| KPE | Container, I.V. | 1 | 1 |
| LGZ | Warmer, Thermal, Infusion Fluid | 1 | 1 |
| LZH | Pump, Infusion, Enteral | 1 | 1 |
Plus 1 more product codes.
Review panels
- General Hospital (15)
- Microbiology (1)
Most recent Acacia, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K142527 | Extension Set with BD Q-Syte Luer Access Split Septum | FPA | 2014-09-19 | 11 |
| K122449 | ENTERAL NUTRITION WARMER | LGZ | 2013-06-13 | 304 |
| K111381 | MEDI-SIS SYRINGE INFUSION SYSTEM | LZH | 2012-01-13 | 241 |
| K103165 | BLOOD SAMPLING SET | FPA | 2010-11-10 | 14 |
| K092986 | ACACIA PISTON SYRINGE | FMF | 2009-10-27 | 29 |
| K972538 | FLOW-EZE BLUNT CANNULA (1999BC) | FMI | 1998-07-15 | 372 |
| K931095 | SPRING LOADED SYRINGE | FMF | 1993-09-16 | 197 |
| K912771 | ACACIAS PHARM/PUMP | LHI | 1992-02-14 | 235 |
| K901063 | LUER LOCK TRANSFER PIN | LHI | 1990-07-06 | 121 |
| K896990 | PHARMULATOR | LHI | 1990-03-23 | 100 |
7 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Acacia, 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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Acacia, Inc. (a text match, not an official crosswalk):
- A4220 — Refill kit for implantable infusion pump (via LZH)
- E0786 — Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter) (via LZH)
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 Laboratories, Inc. (12 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Acacia, Inc.?
FDA lists 17 510(k) clearances under the applicant name “Acacia, Inc.” (first 1979, latest 2014), across 9 product codes in 2 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, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Acacia, Inc. is 100 days.
Which FDA product codes appear under Acacia, Inc.?
The most frequent FDA product codes under this applicant name are LHI (Set, I.V. Fluid Transfer, 5); FMF (Syringe, Piston, 4); FPA (Set, Administration, Intravascular, 2).
Next steps
- See all 17 Acacia, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LHI, Acacia, 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.