Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Hospital Specialty Co. · Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
72 daysmedian FDA review time
207 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K990861 | WOUND DRESSING/ABD PAD, MODEL #10810 | Hospital Specialty Co. | 1999-04-12 | 27 | 0 |
| K941099 | CLEAN-SORB | Hospital Specialty Co. | 1994-09-30 | 207 | 0 |
| K882094 | GARDS DEODORANT SANITARY NAPKIN | Hospital Specialty Co. | 1988-09-22 | 126 | 0 |
| K880454 | AT EASE STRESS PAD | Hospital Specialty Co. | 1988-06-16 | 135 | 0 |
| K880455 | AT EASE ADULT DIAPER | Hospital Specialty Co. | 1988-04-14 | 72 | 0 |
| K822242 | SANITARY/OB NAPKINS | Hospital Specialty Co. | 1982-09-09 | 44 | 0 |
| K822433 | GARDS (UNSCENTED, MENSTRUAL PAD) | Hospital Specialty Co. | 1982-08-30 | 18 | 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