Allen Medical Systems, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Allen Medical Systems, Inc.” (first 1993, latest 1997), across 5 product codes in 2 review panels. Median 510(k) review time under this name: 70 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Baxter, based on public ownership records.
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 |
|---|---|---|---|
| FOX | Stand, Infusion | 1 | 1 |
| FQO | Table, Operating-Room, Ac-Powered | 1 | 1 |
| FWZ | Operating Room Accessories Table Tray | 1 | 1 |
| GDC | Table, Operating-Room, Electrical | 1 | 1 |
| KZD | Infusor, Pressure, For I.V. Bags | 1 | 1 |
Review panels
Most recent Allen Medical Systems, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K971988 | ALLEN, ULTRA AND SMART SOCKETS | FQO | 1997-07-11 | 43 |
| K964273 | DURA-BOARD ARMBOARD | GDC | 1997-01-08 | 72 |
| K960027 | HIGH VOLUME I.V. & IRRIGATION TOWER | FOX | 1996-03-12 | 70 |
| K944779 | CARBON LIGHTS HAND SURGERY TABLE | FWZ | 1994-10-14 | 17 |
| K921168 | ALLEN INFUSION PUMP MODEL 3000 AND IRRIGATION 2000 | KZD | 1993-04-21 | 407 |
Recalls
10 product recalls in 9 recall events; 0 initiated in the last five years. Most recent: 2018-02-21.
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.
- Allen J. Moses, Dds, Ltd. (4 510(k)s)
- Allen Medical Instruments Corp. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Allen Medical Systems, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Allen Medical Systems, Inc.” (first 1993, latest 1997), across 5 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 Allen Medical Systems, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Allen Medical Systems, Inc. is 70 days.
Which FDA product codes appear under Allen Medical Systems, Inc.?
The most frequent FDA product codes under this applicant name are FOX (Stand, Infusion, 1); FQO (Table, Operating-Room, Ac-Powered, 1); FWZ (Operating Room Accessories Table Tray, 1).
Next steps
- See all 5 Allen Medical Systems, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FOX, Allen Medical Systems, 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.