Mps Acacia: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Mps Acacia” (first 2001, latest 2009), across 4 product codes in 3 review panels. Median 510(k) review time under this name: 64 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 |
|---|---|---|---|
| MEB | Pump, Infusion, Elastomeric | 3 | 3 |
| FPA | Set, Administration, Intravascular | 2 | 2 |
| CAZ | Anesthesia Conduction Kit | 1 | 1 |
| KNT | Tubes, Gastrointestinal (And Accessories) | 1 | 1 |
Review panels
Most recent Mps Acacia 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K090809 | MPS ACACIA POWER INJECTABLE INFUSION SET | FPA | 2009-04-28 | 34 |
| K080328 | MPS ACACIA ENTERAL FEEDING TUBE | KNT | 2008-05-14 | 97 |
| K052946 | MPS ACACIA NERVE BLOCK NEEDLE | CAZ | 2005-12-08 | 49 |
| K052451 | MPS ACACIA MEDFLO ELASTOMERIC PUMP | MEB | 2005-12-08 | 92 |
| K032934 | MPS ACACIA SAFEGUARD HUBER DEVICE | FPA | 2003-11-13 | 52 |
| K011117 | MPS ACACIA MEDFLO INFUSION (LI) AND MPS ACACIA MEDFLO INFUSION (LI) KEEP VEIN OPEN (KVO) ELASTOMERIC PUMPS | MEB | 2001-07-09 | 88 |
| K003476 | MPS ACACIA PAIN KIT | MEB | 2001-01-12 | 64 |
Recalls
openFDA lists no recalls under a recalling firm named Mps Acacia.
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 Mps Acacia (a text match, not an official crosswalk):
- A4220 — Refill kit for implantable infusion pump (via MEB)
- E0786 — Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter) (via MEB)
Frequently asked questions
How many FDA 510(k) clearances are listed under Mps Acacia?
FDA lists 7 510(k) clearances under the applicant name “Mps Acacia” (first 2001, latest 2009), across 4 product codes in 3 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 Mps Acacia?
The median time from FDA receipt to decision across 510(k)s cleared under the name Mps Acacia is 64 days.
Which FDA product codes appear under Mps Acacia?
The most frequent FDA product codes under this applicant name are MEB (Pump, Infusion, Elastomeric, 3); FPA (Set, Administration, Intravascular, 2); CAZ (Anesthesia Conduction Kit, 1).
Next steps
- See all 7 Mps Acacia clearances with predicates and recalls
- Run predicate analysis for product code MEB, Mps Acacia'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.