Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
KTC · Predicate Candidate Screening
7 FDA 510(k) clearances under this product code; the 50 most recent screened below.
23 daysmedian FDA review time
104 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K912179 | THE SPRITZ BATH | The Spritz Co. | 1991-08-28 | 104 | 0 |
| K890085 | SIT-N-BATHE SITZ BATH | Drummond Industries, Inc. | 1989-02-13 | 34 | 0 |
| K862600 | SITZ BATH | W. C. Green, D.D.S. | 1986-07-18 | 10 | 0 |
| K851309 | ABCO PLASTIC UTENSILS | Abco Dealers, Inc. | 1985-07-01 | 90 | 0 |
| K841711 | MAC LEE SITZ BATH | Mac Lee Medical Products | 1984-05-07 | 13 | 0 |
| K831762 | SITZ BATH, SINGLE PATIENT USE #8100 | Lsl Industries, Inc. | 1983-06-24 | 23 | 0 |
| K800958 | PERSONAL SITZ BATH KIT | The Healthcare Group Laboratories, Inc. | 1980-05-02 | 9 | 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