Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
FSM — Predicate Candidate Screening
76 FDA 510(k) clearances under this product code; the 50 most recent screened below.
42 daysmedian FDA review time
109 days90th percentile
76clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K971217 | INSTRUMENT TRAY LINER | General Hospital Supply Corp. | 1997-05-06 | 34 | 0 |
| K962328 | SINGLE USE INSTRUMENT TRAY | Medcare Medical Group, Inc. | 1996-08-09 | 64 | 0 |
| K944025 | SURGICAL INSTRUMENT TRAY | Riley Medical, Inc. | 1994-11-22 | 97 | 0 |
| K912106 | ARTHROSCOPY TRAY | Medical Device Inspection Co., Inc. | 1991-08-29 | 108 | 0 |
| K912053 | OPEN HEART TRAY | Medical Device Inspection Co., Inc. | 1991-08-26 | 109 | 0 |
| K912052 | HEART CATH TRAY | Medical Device Inspection Co., Inc. | 1991-08-20 | 103 | 0 |
| K912104 | MAJOR BASIN TRAY | Medical Device Inspection Co., Inc. | 1991-08-09 | 88 | 0 |
| K910570 | SPLINTER TWEEZERS | Solan Scissors Sales | 1991-05-31 | 109 | 0 |
| K911601 | REDDICK TROCAR AND CANNULA | Ideal Medical, Inc. | 1991-05-21 | 41 | 0 |
| K910328 | KEY COMFORT GRIPS | Key Surgical, Inc. | 1991-03-06 | 40 | 0 |
| K905682 | RICHARD-ALLAN CLAMP COVERS | Richard-Allan Medical | 1991-02-19 | 62 | 0 |
| K900376 | HAND SURGERY AND IRRIGATION TRAY (MODEL 3625) | Pmt Corp. | 1990-04-10 | 74 | 0 |
| K894610 | CUSTOM TRAYS, KITS | L H M Ent., Inc. | 1990-03-15 | 238 | 0 |
| K900479 | STERILE LACERATION TRAY CAT. #749 | Busse Hospital Disposables, Inc. | 1990-02-13 | 12 | 0 |
| K895527 | THE NEEDLE COUNT AND SHARPS DISPOSAL SYSTEM | Quantitative Technologies, Inc. | 1989-10-06 | 24 | 0 |
| K883193 | CASF STERILIZATION TRAY | Terray Manufacturing, Inc. | 1988-08-10 | 13 | 0 |
| K883125 | CASF STERILIZATION TRAY | Terray Manufacturing, Inc. | 1988-08-10 | 15 | 0 |
| K882617 | BREVET CASSETTE STERILIZATION MODULE | Brevet, Inc. | 1988-07-28 | 34 | 0 |
| K871924 | STERILIZATION TRAY, TMJ INSTRUMENT SET | Arthropedics, Inc. | 1987-06-01 | 14 | 0 |
| K871478 | SURGICAL PACKS, SURGICAL KITS AND SURGICAL TRAYS | Procedure Pak, Inc. | 1987-05-07 | 23 | 0 |
| K870892 | MEDSURG PERCUTANEOUS ASPIRATION BIOPSY (PAB) TRAY | Medsurg Industries, Inc. | 1987-04-10 | 36 | 0 |
| K870417 | RCT-1, RCT-2, RCT-3 ARTHROGRAM TRAY | North Coast Medi-Tek | 1987-03-05 | 30 | 0 |
| K864920 | SCANLAN (TM) INSTRUMENT TRAY | Scanlan Intl., Inc. | 1987-01-12 | 27 | 0 |
| K863726 | INSTRUMENT STERILIZATION TRAY | Medical Technology Development Corp. | 1986-10-14 | 21 | 0 |
| K862629 | SURGICAL LASER ACCESSORIES (SLA) CASE | Simpson/Basye, Inc. | 1986-07-17 | 7 | 0 |
| K862154 | VENESECTION EQUIPMENT STORAGE TRAY | Rmp Co. | 1986-06-16 | 11 | 0 |
| K861530 | SURGICAL PACKS, KITS AND TRAYS | Medical Concepts Development, Inc. | 1986-05-30 | 36 | 0 |
| K861525 | DISPOSABLE SURG KITS/GOWNS/GUARDS/COVERS/MASKS | D & D Products, Inc. | 1986-05-06 | 18 | 0 |
| K860160 | OPERATING ROOM TRAY | Medical Design Concepts, Inc. | 1986-02-27 | 42 | 0 |
| K854746 | SURGICAL INSTRUMENT TRAY | Zbi, Inc. | 1985-12-17 | 21 | 0 |
| K844613 | GENERAL PURPOSE INSTRUMENT TRAYS SUTURE REMOVAL TR | Packaging Technologies, Inc. | 1985-01-10 | 44 | 0 |
| K844652 | C.A.S.E. CONTAINER | General Medical Co. | 1984-12-12 | 13 | 0 |
| K843627 | VENESECTION TRAY, ADULT 6050 | Pro-Lab, Inc. | 1984-12-04 | 81 | 0 |
| K844286 | FLASH GUARD PLASTIC VERSION | Sparco, Inc. | 1984-11-19 | 14 | 0 |
| K844002 | HU-FRIEDY IMS CASSETTE SYSTEM | Hu-Friedy Mfg. Co., Inc. | 1984-11-08 | 27 | 0 |
| K843564 | MSI SURGI-GRADE SUTURE TRAY | Medical Sterilization, Inc. | 1984-10-31 | 51 | 0 |
| K843561 | MSI SURGI-GRADE UNIVERSAL TRACH TRAY | Medical Sterilization, Inc. | 1984-10-24 | 44 | 0 |
| K843563 | MSI SURGI-GRADE INCISION & DRAIN TRAY | Medical Sterilization, Inc. | 1984-10-23 | 43 | 0 |
| K843723 | STERILE INSTRUMENT TRAYS-VARIOUS | E.M. Adams | 1984-10-23 | 29 | 0 |
| K842009 | ABDOMINAL PARACENTESIS TRAY | Jayco Pharmaceuticals | 1984-10-23 | 159 | 0 |
| K840976 | VARIOUS DISPOSABLE KITS/TRAYS/INSTRU | Carapace, Inc. | 1984-05-31 | 86 | 0 |
| K841122 | TRACHEOSTOMY CARE TRAY | Medcare Products | 1984-04-25 | 41 | 0 |
| K840021 | OPERATING ROOM TRAY SET | Medi-Plast Intl., Inc. | 1984-03-15 | 70 | 0 |
| K833058 | GEN. PURPOSE INSTRUMENT TRAYS & | Inter-Med Corp. | 1984-01-31 | 145 | 0 |
| K832137 | CONVERTORS FLASH STERILIZING TRAY | American Convertors Div., American Pharmaseal | 1983-08-12 | 42 | 0 |
| K830219 | VARIOUS INSTRUMENTS & INSTRUMENT TRAYS | Ascep, Inc. | 1983-04-12 | 78 | 0 |
| K823854 | MEDCARE SUTURE REMOVAL TRAYS | Medcare Products | 1983-03-31 | 99 | 0 |
| K823856 | MEDCARE GENERAL PURPOSE TRAY | Medcare Products | 1983-01-14 | 23 | 0 |
| K823438 | HANDI-TRAY | Treace Medical, Inc. | 1983-01-14 | 59 | 0 |
| K823853 | MEDCARE WOUND CLOSURE TRAY | Medcare Products | 1983-01-14 | 23 | 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