Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Nice-Pak Products, Inc. · Predicate Candidate Screening

9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

56 daysmedian FDA review time
88 days90th percentile
9clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K974768PDI STERILE LUBRICATING JELLYNice-Pak Products, Inc.1998-01-16250
K840343PDI PREPMASTER WET PACK VAGINAL-X21477Nice-Pak Products, Inc.1984-03-27810
K840342PDI PREPMASTER WET PACK PATIENT PREP KITNice-Pak Products, Inc.1984-03-27810
K840344PDI PREPMASTER WET PACK MINOR PROCEDURENice-Pak Products, Inc.1984-03-26800
K833549PDI SURGICAL SCRUB/BRUSH T150-70Nice-Pak Products, Inc.1983-11-28880
K810337PDI SURGICAL SCRUB SPONGE-BRUSH-T15070Nice-Pak Products, Inc.1981-02-26170
K781539ISO-CARE KITNice-Pak Products, Inc.1978-11-03560
K780279ICE-PAK, PDINice-Pak Products, Inc.1978-04-10480
K780400DEN-Z-ORBNice-Pak Products, Inc.1978-03-27140

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