Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Carrom Healthcare, Inc. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
61 daysmedian FDA review time
100 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K854832 | EVEREST & JENNING SERIES 5000 MODULAR BED | Carrom Healthcare, Inc. | 1986-02-04 | 63 | 0 |
| K854867 | EVEREST & JENNINGS TRADITION-STANDARD BED L109684& | Carrom Healthcare, Inc. | 1986-02-04 | 61 | 0 |
| K854937 | CARROM CARELIFE SERIES 40000 MODULAR BES SYSTEM | Carrom Healthcare, Inc. | 1986-02-04 | 56 | 0 |
| K854776 | EVEREST & JENNINGS BED MODEL NO. L109564 & L108564 | Carrom Healthcare, Inc. | 1985-12-13 | 14 | 0 |
| K853270 | CENTERCOM CONTROL | Carrom Healthcare, Inc. | 1985-11-13 | 100 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda