Reimers Systems, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Reimers Systems, Inc.” (first 1995, latest 2011), across 1 product code in 1 review panel. Median 510(k) review time under this name: 92 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 |
|---|---|---|---|
| CBF | Chamber, Hyperbaric | 5 | 5 |
Review panels
- Anesthesiology (5)
Most recent Reimers Systems, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K102831 | RSI 4200 | CBF | 2011-08-19 | 324 |
| K962871 | ODS1 - HOOD DRIVER | CBF | 1996-10-23 | 92 |
| K962869 | GSP1 - GAS SELECTION PANEL | CBF | 1996-10-23 | 92 |
| K954387 | T CLASS HYPERBARIC FACILITIES | CBF | 1995-12-15 | 118 |
| K951125 | LIFEFORCE CLINICAL HYPERBARIC FACILITY | CBF | 1995-06-02 | 81 |
Recalls
openFDA lists no recalls under a recalling firm named Reimers Systems, 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 Reimers Systems, Inc. (a text match, not an official crosswalk):
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.
- Reimers and Janssen GmbH (2 510(k)s)
- Reimers Engineering, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Reimers Systems, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Reimers Systems, Inc.” (first 1995, latest 2011), across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Reimers Systems, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Reimers Systems, Inc. is 92 days.
Which FDA product codes appear under Reimers Systems, Inc.?
The most frequent FDA product codes under this applicant name are CBF (Chamber, Hyperbaric, 5).
Next steps
- See all 5 Reimers Systems, Inc. clearances with predicates and recalls
- Run predicate analysis for product code CBF, Reimers 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 (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.