Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
LRP — Predicate Candidate Screening
22 FDA 510(k) clearances under this product code; the 50 most recent screened below.
63 daysmedian FDA review time
260 days90th percentile
22clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K963723 | LACERATION TRAY | Grand Medical Products | 1996-11-27 | 72 | 0 |
| K951811 | OSTEOTECH MUSCULOSKELETAL TISSUE RECOVERY PACK | Osteotech, Inc. | 1995-05-31 | 42 | 0 |
| K940239 | EYE TRAY | Cush Medical Products | 1994-06-28 | 160 | 0 |
| K935621 | CUSTOM ENT PACKS | Associated Medical | 1994-03-30 | 128 | 0 |
| K940646 | ORTHOPEDIC TRAY PRODUCT LINE | Cushindu | 1994-03-11 | 24 | 0 |
| K940444 | GENERAL SURGERY TRAY | Cush Medical Products | 1994-03-07 | 34 | 0 |
| K922126 | HOSPITAL KIT ENT 1125 | Savoy Medical Supply Co., Inc. | 1993-01-21 | 260 | 0 |
| K912105 | EYE TRAY | Medical Device Inspection Co., Inc. | 1991-08-29 | 108 | 0 |
| K903963 | KITS AND TRAYS FOR ONE TIME USE ONLY | Apk Technology | 1991-07-29 | 335 | 0 |
| K903962 | INSTRUMENTS FOR ONE TIME USE/ DISPOSABLE | Apk Technology | 1991-07-29 | 335 | 0 |
| K905462 | PROCEDURE TRAY/FOR VARIOUS OPHTHALMIC PROCEDURES | Angiosystems, Inc. | 1991-02-06 | 63 | 0 |
| K903544 | CAREKITS(TM) INCISION/DRAINAGE/SUTURE REMOVAL KITS | J.J. Skinner, Inc. | 1990-08-31 | 25 | 0 |
| K890071 | STERILE LACERATION TRAY | Mumtaz I. Malik | 1989-01-24 | 15 | 0 |
| K883098 | SITE STERILIZATION TRAYS FOR OPHTHALMIC USE | Site Microsurgical Systems, Inc. | 1988-08-18 | 27 | 0 |
| K882275 | STERILE PACK (PROCEDURAL TRAY/KITS) | East Texas Lighthouse For the Blind | 1988-07-18 | 48 | 0 |
| K881095 | KOI(TM) INSTRUMENT TRAYS | CooperVision, Inc. | 1988-04-06 | 22 | 0 |
| K874665 | SECURLINE FINE NEEDLE ASPIRATION BIOPSY TRAY | Precision Dynamics Corp. | 1988-01-20 | 68 | 0 |
| K873469 | TODD MEDICAL/SKILLED CARE PRODUCTS | Todd Medical, Inc. | 1987-10-29 | 62 | 0 |
| K873290 | LACERATION AND INSTRUMENT TRAYS | Advantage Medical Systems, Inc. | 1987-09-24 | 38 | 0 |
| K873439 | LACERATION TRAY | Ulti-Med Intl., Inc. | 1987-09-11 | 15 | 0 |
| K861142 | MASTER KIT B | Pro-Lab, Inc. | 1986-07-10 | 106 | 0 |
| K760497 | TRAY, SERVICE | Landmark Plastics | 1976-11-12 | 81 | 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