Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
ILP — Predicate Candidate Screening
21 FDA 510(k) clearances under this product code; the 50 most recent screened below.
16 daysmedian FDA review time
27 days90th percentile
21clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K844890 | TELL ME TAGS - NONPOWERED COMMUNICATION SYS | Mina Manufacturers, Inc. | 1985-03-08 | 81 | 0 |
| K840112 | SPEECH TEACHER | Joseph A. Resnick | 1984-03-22 | 73 | 0 |
| K831546 | ADAPTIVE PENS & LAP DESK | Fred Sammons, Inc. | 1983-06-08 | 27 | 0 |
| K823625 | MOUTH STICK KIT | Fred Sammons, Inc. | 1982-12-30 | 24 | 0 |
| K823608 | PICTURES & WORD IDENTIFICATION CVA PAT | Fred Sammons, Inc. | 1982-12-30 | 24 | 0 |
| K823624 | HOLDER FOR MOUTH STICK | Fred Sammons, Inc. | 1982-12-30 | 24 | 0 |
| K823612 | ADJ. WOODEN BOARD FOR WRITING | Fred Sammons, Inc. | 1982-12-30 | 24 | 0 |
| K823609 | KIT OF WORDS & LTRS TO RE-LEARN-BK4014 | Fred Sammons, Inc. | 1982-12-22 | 16 | 0 |
| K823616 | PLASTIC SLIP-ON PEN/PENCIL HOLDER | Fred Sammons, Inc. | 1982-12-22 | 16 | 0 |
| K823614 | FLEXIBLE HOLDER TO HOLD PHONE RECEIVER | Fred Sammons, Inc. | 1982-12-22 | 16 | 0 |
| K823610 | BK-4015 ECONOMY COMMUNICATION SHEET | Fred Sammons, Inc. | 1982-12-22 | 16 | 0 |
| K823617 | PLASTIC SLIP-ON POINTS W/RUBBER TIP FOR | Fred Sammons, Inc. | 1982-12-22 | 16 | 0 |
| K823613 | PLASTIC STOP TO HOLD TELEPHONE BUTTON | Fred Sammons, Inc. | 1982-12-22 | 16 | 0 |
| K823615 | TELEPHONE ADAPTOR-PERSONS CANT ANSWER | Fred Sammons, Inc. | 1982-12-22 | 16 | 0 |
| K821644 | VACUUM WAND AND UNI-READER | Fred Sammons, Inc. | 1982-06-11 | 8 | 0 |
| K811483 | STIM STAND | Fred Sammons, Inc. | 1981-06-16 | 21 | 0 |
| K811487 | BOOK HOLDER | Fred Sammons, Inc. | 1981-06-12 | 17 | 0 |
| K810452 | NON-POWERED COMMUNICATION SYSTEMS | Fred Sammons, Inc. | 1981-03-04 | 13 | 0 |
| K781204 | BOOK HOLDER | Fred Sammons, Inc. | 1978-07-31 | 17 | 0 |
| K770032 | PAGE TURNER | Possum, Inc. | 1977-01-12 | 6 | 0 |
| K761117 | KEYBOARD SHEILDS | 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