Carrom Healthcare, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Carrom Healthcare, Inc.” (first 1985, latest 1986), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 61 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 |
|---|---|---|---|
| FNL | Bed, Ac-Powered Adjustable Hospital | 4 | 4 |
| FNJ | Bed, Manual | 1 | 1 |
Review panels
- General Hospital (5)
Most recent Carrom Healthcare, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K854937 | CARROM CARELIFE SERIES 40000 MODULAR BES SYSTEM | FNL | 1986-02-04 | 56 |
| K854867 | EVEREST & JENNINGS TRADITION-STANDARD BED L109684& | FNL | 1986-02-04 | 61 |
| K854832 | EVEREST & JENNING SERIES 5000 MODULAR BED | FNL | 1986-02-04 | 63 |
| K854776 | EVEREST & JENNINGS BED MODEL NO. L109564 & L108564 | FNJ | 1985-12-13 | 14 |
| K853270 | CENTERCOM CONTROL | FNL | 1985-11-13 | 100 |
Recalls
openFDA lists no recalls under a recalling firm named Carrom Healthcare, 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Carrom Healthcare, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Carrom Healthcare, Inc.” (first 1985, latest 1986), across 2 product codes 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 Carrom Healthcare, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Carrom Healthcare, Inc. is 61 days.
Which FDA product codes appear under Carrom Healthcare, Inc.?
The most frequent FDA product codes under this applicant name are FNL (Bed, Ac-Powered Adjustable Hospital, 4); FNJ (Bed, Manual, 1).
Next steps
- See all 5 Carrom Healthcare, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FNL, Carrom Healthcare, 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.