Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Customed, Inc. — Predicate Candidate Screening
36 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
87 daysmedian FDA review time
256 days90th percentile
36clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K974647 | FANFOLD DRAPE 41 X 57 PRODUCT NO. 900-633, RECORDER NO. 0633 | Customed, Inc. | 1998-01-05 | 24 | 0 |
| K971920 | GOWN POLY REINFORCED LARGE(PRODUCT NO.900-522)/(REORDER NO. | Customed, Inc. | 1997-12-04 | 195 | 10 |
| K964011 | SUCTION CATHETER TRAY PRODUCT NO. 900277 | Customed, Inc. | 1996-11-25 | 49 | 1 |
| K962652 | URINARY DRAINAGE BAG, (REORDER NO. 0749 - PRODUCT NO. 900-74 | Customed, Inc. | 1996-10-04 | 88 | 11 |
| K962596 | CUSTOMED BLOOD EXTRACTION KIT | Customed, Inc. | 1996-09-27 | 87 | 0 |
| K961442 | UNIVERSAL DRAINAGE TRAY | Customed, Inc. | 1996-05-09 | 24 | 2 |
| K953678 | STERIMED STERIZATION WRAPPER (NON-STERILE) | Customed, Inc. | 1995-10-02 | 56 | 0 |
| K950295 | WOUND CLOSURE/LACERATION TRAY | Customed, Inc. | 1995-04-18 | 84 | 14 |
| K942177 | FOLEY CATHETERIZATION TRAY | Customed, Inc. | 1994-09-08 | 127 | 0 |
| K925017 | IV PREP KIT (NON-STERILE) | Customed, Inc. | 1993-08-27 | 337 | 0 |
| K925018 | IV PREP KIT W/O DRESSING (NON-STERILE) | Customed, Inc. | 1993-08-27 | 337 | 0 |
| K930986 | BLOOD GAS KIT (NON-STERILE) REORDER NO. 0560 | Customed, Inc. | 1993-07-14 | 139 | 0 |
| K925020 | TRACHEOSTOMY CARE KIT (STERILE) | Customed, Inc. | 1993-07-07 | 286 | 3 |
| K925021 | TPN TRAY (STERILE) | Customed, Inc. | 1993-06-07 | 256 | 1 |
| K925015 | STERILE SUTURE REMOVAL KIT | Customed, Inc. | 1993-06-07 | 256 | 2 |
| K924809 | IRRIGATION TRAY W/ BULB SYRINGE | Customed, Inc. | 1993-06-07 | 256 | 3 |
| K925016 | PREP SHAVE KIT (NON-STERILE) | Customed, Inc. | 1993-04-26 | 214 | 1 |
| K925022 | SURGICAL TRAY (STERILE) | Customed, Inc. | 1993-04-26 | 214 | 0 |
| K904693 | CUSTOMED CARDIOVASCULAR PACK | Customed, Inc. | 1991-01-02 | 78 | 6 |
| K904694 | CUSTOMED ANGIODRAPE PACK FEMORAL | Customed, Inc. | 1991-01-02 | 78 | 11 |
| K902191 | CUSTOMED LAP PACK II | Customed, Inc. | 1990-10-31 | 168 | 3 |
| K901705 | CUSTOMED CYSTO PACK II | Customed, Inc. | 1990-10-31 | 202 | 0 |
| K902032 | O. B. PACK IV | Customed, Inc. | 1990-09-28 | 147 | 2 |
| K902274 | CUSTOMED CYSTO PACK I | Customed, Inc. | 1990-09-20 | 122 | 5 |
| K902885 | CUSTOMED BASIC PACK II | Customed, Inc. | 1990-09-19 | 79 | 0 |
| K902886 | CUSTOMED BASIC PACK III | Customed, Inc. | 1990-09-19 | 79 | 11 |
| K902884 | CUSTOMED BASIC PACK I | Customed, Inc. | 1990-09-19 | 79 | 0 |
| K902887 | CUSTOMED ARTHROSCOPY PACK | Customed, Inc. | 1990-09-10 | 70 | 0 |
| K902888 | CUSTOMED ORTHOPEDIC II | Customed, Inc. | 1990-09-10 | 70 | 0 |
| K903336 | CUSTOMED HIP PACT | Customed, Inc. | 1990-08-29 | 35 | 0 |
| K902273 | O. B. PACK III | Customed, Inc. | 1990-08-21 | 92 | 2 |
| K902271 | O. B. PACK I | Customed, Inc. | 1990-08-15 | 86 | 5 |
| K902272 | O. B. PACK II | Customed, Inc. | 1990-08-15 | 86 | 0 |
| K902030 | CUSTOMED LAP PACK III | Customed, Inc. | 1990-07-12 | 69 | 2 |
| K902031 | CUSTOMED LAP PACK IV | Customed, Inc. | 1990-07-12 | 69 | 8 |
| K902029 | CUSTOMED LAP PACK I | Customed, Inc. | 1990-07-12 | 69 | 4 |
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