Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
Custom Pack Reliability — Predicate Candidate Screening
21 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
76 daysmedian FDA review time
128 days90th percentile
21clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K960205 | CPR TRACHEOTOMY CARE TRAY | Custom Pack Reliability | 1996-08-27 | 224 | 0 |
| K960243 | CPR C-SECTION DELIVERY PACK | Custom Pack Reliability | 1996-05-23 | 128 | 0 |
| K960239 | CPR D & C TRAY | Custom Pack Reliability | 1996-05-23 | 128 | 0 |
| K960216 | CPR SUCTION CATHETER KIT | Custom Pack Reliability | 1996-04-15 | 90 | 0 |
| K960213 | CPR TOTAL HIP PACK | Custom Pack Reliability | 1996-04-12 | 87 | 0 |
| K960211 | CPR TOTAL KNEE PACK | Custom Pack Reliability | 1996-04-12 | 87 | 0 |
| K960210 | CPR ORTHO HAND PACK | Custom Pack Reliability | 1996-04-12 | 87 | 0 |
| K960206 | CPR DRESSING CHANGE TRAY | Custom Pack Reliability | 1996-04-12 | 87 | 0 |
| K960209 | CPR HEART PACK | Custom Pack Reliability | 1996-04-04 | 79 | 0 |
| K960212 | CPR IRRIGATION TRAY | Custom Pack Reliability | 1996-04-01 | 76 | 0 |
| K960214 | CPR FOLEY CAHTETER KIT | Custom Pack Reliability | 1996-04-01 | 76 | 0 |
| K960215 | CPR URETHRAL CATHETER TRAY | Custom Pack Reliability | 1996-04-01 | 76 | 0 |
| K960217 | CPR URINE BAG | Custom Pack Reliability | 1996-03-28 | 72 | 0 |
| K960223 | CPR YANKAUER | Custom Pack Reliability | 1996-03-28 | 72 | 0 |
| K960218 | CONNECTING TUBING | Custom Pack Reliability | 1996-03-28 | 72 | 0 |
| K960238 | CPR SUTURE REMOVAL KIT | Custom Pack Reliability | 1996-03-28 | 72 | 0 |
| K960236 | CPR LAP SPONGES | Custom Pack Reliability | 1996-03-28 | 72 | 0 |
| K960208 | CPR BASIC SET-UP TRAY | Custom Pack Reliability | 1996-03-28 | 72 | 0 |
| K960241 | CPR GENERAL SURGERY TRAY | Custom Pack Reliability | 1996-03-22 | 66 | 0 |
| K960242 | CPR EYE TRAY | Custom Pack Reliability | 1996-03-12 | 56 | 0 |
| K960207 | CPR LACERATION TRAY | Custom Pack Reliability | 1996-02-27 | 42 | 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