Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Medcare Medical Group, Inc. · Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
77 daysmedian FDA review time
172 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K973497 | HUBERLOC | Medcare Medical Group, Inc. | 1998-01-13 | 120 | 0 |
| K970152 | BIOPSY TRAY | Medcare Medical Group, Inc. | 1997-03-05 | 48 | 0 |
| K962849 | CATHETER INSERTION TRAY | Medcare Medical Group, Inc. | 1996-10-07 | 77 | 0 |
| K961075 | MEDCARE REGIONAL ANETHESIA KIT | Medcare Medical Group, Inc. | 1996-09-06 | 172 | 0 |
| K962328 | SINGLE USE INSTRUMENT TRAY | Medcare Medical Group, Inc. | 1996-08-09 | 64 | 0 |
| K962527 | GENERAL PURPOSE DENTAL TRAY | Medcare Medical Group, Inc. | 1996-08-01 | 35 | 0 |
| K961880 | MEDCARE SUCTION CONNECTING TUBING | Medcare Medical Group, Inc. | 1996-07-19 | 65 | 0 |
| K961167 | MEDCARE TRACHEOSTOMY CARE TRAY | Medcare Medical Group, Inc. | 1996-07-02 | 99 | 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