Clinical Resources, Inc.: FDA filings under this applicant name
FDA lists 14 510(k) clearances under the applicant name “Clinical Resources, Inc.” (first 1994, latest 1995), across 8 product codes in 3 review panels. Median 510(k) review time under this name: 72 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 |
|---|---|---|---|
| FRG | Wrap, Sterilization | 5 | 5 |
| EFQ | Gauze/Sponge, Internal | 3 | 3 |
| BTO | Tube, Tracheostomy (W/Wo Connector) | 1 | 1 |
| EYN | Tray, Irrigation, Sterile | 1 | 1 |
| FXX | Mask, Surgical | 1 | 1 |
| GDY | Gauze/Sponge, Internal, X-Ray Detectable | 1 | 1 |
| LRS | I.V. Start Kit | 1 | 1 |
| MCZ | Suture Removal Kit | 1 | 1 |
Review panels
Most recent Clinical Resources, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K941470 | TRACHEOSTOMY CARE KIT | BTO | 1995-02-14 | 323 |
| K944882 | IRRIGATION TRAY | EYN | 1995-01-12 | 101 |
| K944881 | SKIN SCRUB TRAY | FRG | 1994-12-27 | 85 |
| K945021 | FLUFF GAUZE SPONGE | EFQ | 1994-12-23 | 72 |
| K945020 | FLUFF GAUZE SPONGE | EFQ | 1994-12-23 | 72 |
| K945019 | FLUFF GAUXZE ROLL | EFQ | 1994-12-23 | 72 |
| K944879 | GAUZE SPONGES | GDY | 1994-12-23 | 81 |
| K944880 | BODILY FLUID DISPOSAL KIT | FXX | 1994-12-15 | 73 |
| K941471 | CENTRAL LINE DRESSING CHANGE TRAY | FRG | 1994-05-12 | 45 |
| K941469 | IV START KIT | LRS | 1994-05-12 | 45 |
4 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Clinical Resources, 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.
- Clinical Data, Inc. (37 510(k)s)
- Clinical Sciences, Inc. (30 510(k)s)
- Clinical Assays, Inc. (27 510(k)s)
- Clinical Controls, Inc. (18 510(k)s)
- Clinical Innovations, LLC (18 510(k)s)
- Clinical Technology Corp. (12 510(k)s)
- Clinical Connections, Inc. (10 510(k)s)
- Clinical Diagnostics, Inc. (8 510(k)s)
- Clinical Convenience Products, Inc. (6 510(k)s)
- Clinical Laserthermia Systems, AB (6 510(k)s)
- Clinical Neuro Systems, LLC (5 510(k)s)
- Clinical Bioresearch (4 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Clinical Resources, Inc.?
FDA lists 14 510(k) clearances under the applicant name “Clinical Resources, Inc.” (first 1994, latest 1995), across 8 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 Clinical Resources, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Clinical Resources, Inc. is 72 days.
Which FDA product codes appear under Clinical Resources, Inc.?
The most frequent FDA product codes under this applicant name are FRG (Wrap, Sterilization, 5); EFQ (Gauze/Sponge, Internal, 3); BTO (Tube, Tracheostomy (W/Wo Connector), 1).
Next steps
- See all 14 Clinical Resources, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FRG, Clinical Resources, 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.