Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Superior Healthcare Group, Inc. · Predicate Candidate Screening
14 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
73 daysmedian FDA review time
173 days90th percentile
14clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K925530 | INSTRUMENT WARMER | Superior Healthcare Group, Inc. | 1993-06-18 | 228 | 0 |
| K924764 | OVERTUBE FOR ENDSCOPIC LIGATOR | Superior Healthcare Group, Inc. | 1993-03-15 | 173 | 0 |
| K905755 | NON-STERILE PATIENT EXAMINATION GLOVES | Superior Healthcare Group, Inc. | 1991-03-08 | 71 | 0 |
| K903347 | SODIUM CHLORIDE SOLUTION | Superior Healthcare Group, Inc. | 1990-12-13 | 141 | 0 |
| K904216 | STERILE WATER SOLUTION CATALOG # 10000 | Superior Healthcare Group, Inc. | 1990-11-16 | 65 | 0 |
| K903340 | STERILE URETHRAL CATHETER PROCEDURE KITS | Superior Healthcare Group, Inc. | 1990-10-04 | 71 | 7 |
| K896321 | NO. 34100 - 8 FR & NO. 34400 - 14 FR CLOSED TRACH. | Superior Healthcare Group, Inc. | 1989-11-13 | 12 | 0 |
| K894676 | STERILE LATEX EXAM GLOVES | Superior Healthcare Group, Inc. | 1989-08-17 | 24 | 0 |
| K891445 | LATEX EXAMINATION GLOVES | Superior Healthcare Group, Inc. | 1989-08-09 | 147 | 0 |
| K892426 | NO. 86500 - ENDOSCOPIC JET WASHER | Superior Healthcare Group, Inc. | 1989-06-22 | 73 | 0 |
| K885339 | FLOW THRU 16,18,20,22 FR REPLACE. GASTRO TUBE KIT | Superior Healthcare Group, Inc. | 1989-03-01 | 63 | 0 |
| K880201 | REPLACEMENT SILICONE GASTROSTOMY TUBE KIT #87600 | Superior Healthcare Group, Inc. | 1988-04-14 | 90 | 0 |
| K880648 | ENDOSCOPIC ELASTIC BAND LIGATOR | Superior Healthcare Group, Inc. | 1988-04-06 | 49 | 0 |
| K853353 | 88000 GASTROSTOMY-JEJUNAL FEEDING TUBE KIT | Superior Healthcare Group, Inc. | 1985-11-04 | 84 | 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