Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
ILI — Predicate Candidate Screening
21 FDA 510(k) clearances under this product code; the 50 most recent screened below.
22 daysmedian FDA review time
33 days90th percentile
21clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K912661 | MATRX, PYRAMID TRIANGLE BANDAGE | Matrix Medica, Inc. | 1991-08-21 | 64 | 0 |
| K831549 | ARM SLINGS | Fred Sammons, Inc. | 1983-06-30 | 49 | 0 |
| K831706 | SATO FAMILY FIRST AID KIT | Food and Drug Service, Inc. | 1983-06-24 | 29 | 0 |
| K823808 | VARIOUS ARM SLING | Danek Medical, Inc. | 1983-01-14 | 28 | 0 |
| K823810 | A.C. SPLINT | Danek Medical, Inc. | 1983-01-14 | 28 | 0 |
| K823664 | UNIVERSAL SLING, SLING & SWATHE | Warm & Form, Orthopedic Materials | 1982-12-30 | 24 | 0 |
| K823162 | UNIVERSAL SLING, SLING & SWATHE | Warm & Form, Orthopedic Materials | 1982-11-10 | 16 | 0 |
| K820590 | ORTHOPEDIC SOFT GOODS | Abco Dealers, Inc. | 1982-03-26 | 22 | 0 |
| K812477 | ARM SLING, POUCH TYPE | Maddak, Inc. | 1981-09-14 | 14 | 0 |
| K812478 | MADDACOMFORT SLING | Maddak, Inc. | 1981-09-14 | 14 | 0 |
| K812480 | LIMB HOLDER ARM SLING | Maddak, Inc. | 1981-09-14 | 14 | 0 |
| K812345 | ARM SLINGS | Fred Sammons, Inc. | 1981-09-11 | 24 | 0 |
| K803212 | BAUER & BLACK ARM SLING W/DETACH. POUCH | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1981-01-08 | 22 | 0 |
| K803139 | CONPHAR ARM SLINGS | Conphar, Inc. | 1981-01-08 | 27 | 0 |
| K802006 | TRIANGULAR BANDAGE CAT.#191 | Pollak (Intl.), Ltd. | 1980-09-16 | 27 | 0 |
| K801713 | BK-6157-02 C.V.A SLING, MEDIUM&LARGE | Fred Sammons, Inc. | 1980-08-07 | 14 | 0 |
| K801626 | ARM SLING | The Owenby Co. | 1980-07-28 | 13 | 0 |
| K801531 | ARM SLING | The Owenby Co. | 1980-07-21 | 20 | 0 |
| K771031 | STROKE SLING | Stat Medical Corp. | 1977-06-27 | 18 | 0 |
| K760574 | ECONOMY IMMOBILIZATION AND VELPEAN SLING | Richard'S Medical Equip., Inc. | 1976-10-06 | 33 | 0 |
| K760250 | BANDAGE, TRIANGULAR NO. 8068 | Johnson & Johnson Professionals, Inc. | 1976-07-26 | 7 | 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