Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
ILS — Predicate Candidate Screening
31 FDA 510(k) clearances under this product code; the 50 most recent screened below.
17 daysmedian FDA review time
46 days90th percentile
31clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K852049 | MEDICAL TOILET SEAT | Pedro Aleman | 1985-06-24 | 47 | 0 |
| K842651 | COMMODE CHAIR 98200 | Guardian Products Co., Inc. | 1984-08-07 | 28 | 0 |
| K830853 | LAVATORY SEAT HEIGHTENER | Lic-Orthion | 1983-06-08 | 83 | 0 |
| K831547 | RAISED TOILET SEATS & NAIL CLIPPERS | Fred Sammons, Inc. | 1983-06-08 | 27 | 0 |
| K830425 | TOILET SEAT RAISED | Maddak, Inc. | 1983-05-09 | 89 | 0 |
| K830852 | SHOWER STOOL W/HANDLES | Lic-Orthion | 1983-04-05 | 19 | 0 |
| K823641 | BATHING CHAIR FOR CHILD | Fred Sammons, Inc. | 1983-01-21 | 46 | 0 |
| K823626 | DISPOSABLE TOOTH BRUSH | Fred Sammons, Inc. | 1982-12-30 | 24 | 0 |
| K823606 | PLASTIC BREAK RESISTANT MIRROR | Fred Sammons, Inc. | 1982-12-28 | 22 | 0 |
| K823155 | LAVATORY SEAT HEIGHTENER | Orthion Corp. | 1982-11-05 | 16 | 0 |
| K823156 | COLLAPSABLE LAVATORY HEIGHTENER | Orthion Corp. | 1982-11-05 | 16 | 0 |
| K821860 | BK-6477 THE DERBY RAISED TOILET SEAT | Fred Sammons, Inc. | 1982-07-02 | 9 | 0 |
| K821638 | HYGIENE ADAPTORS | Fred Sammons, Inc. | 1982-06-11 | 8 | 0 |
| K821009 | BATHTUB GRAB BAR | Guardian Products Co., Inc. | 1982-04-21 | 9 | 0 |
| K813635 | CHILDS TOILET TRAINER HYGIENE AIDS | Fred Sammons, Inc. | 1982-01-19 | 21 | 0 |
| K812352 | HYGIENE ADAPTORS | Fred Sammons, Inc. | 1981-09-14 | 27 | 0 |
| K812483 | SECURA BATH SEAT | Maddak, Inc. | 1981-09-14 | 14 | 0 |
| K811301 | TUBMATE | American Stair-Glide Corp. | 1981-05-27 | 16 | 0 |
| K810456 | HYGIENE ADAPTORS | Fred Sammons, Inc. | 1981-03-04 | 13 | 0 |
| K802511 | GARELICK COMMODE | Garelick Mfg. Co. | 1980-11-12 | 28 | 0 |
| K791423 | TOILET TRAINER FOR HANDICAPPED CHILD | Kaye Products, Inc. | 1979-08-10 | 10 | 0 |
| K790531 | ANUS STIMULATOR | Maddak, Inc. | 1979-04-26 | 42 | 0 |
| K790175 | SEMI-RECLINING BATH CHARI & BELT | Fred Sammons, Inc. | 1979-02-22 | 27 | 0 |
| K790178 | WATER POWERED BATH CHAIR LIFT | Fred Sammons, Inc. | 1979-02-08 | 13 | 0 |
| K781614 | MOTOR RISER TOLIT LIFT | Motor Riser Chairs , Ltd. | 1978-10-03 | 22 | 0 |
| K781205 | TOILET AID | Fred Sammons, Inc. | 1978-07-31 | 17 | 0 |
| K761129 | CONTOURED RAISED TOILET SEAT | Fred Sammons, Inc. | 1976-12-02 | 13 | 0 |
| K761126 | EXTRA LARGE LONG HANDLED SPONGE | Fred Sammons, Inc. | 1976-12-02 | 13 | 0 |
| K761125 | LONG HANDLED SPONGE | Fred Sammons, Inc. | 1976-12-02 | 13 | 0 |
| K761130 | BATHTUB RAILS | Fred Sammons, Inc. | 1976-12-02 | 13 | 0 |
| K761127 | LONG HANDLED BATH BRUSH | Fred Sammons, Inc. | 1976-12-02 | 13 | 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