Atlas FDA

Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

Kawasumi Laboratories, Inc. · Predicate Candidate Screening

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

92 daysmedian FDA review time
248 days90th percentile
11clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K190485Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MKawasumi Laboratories, Inc.2019-07-081310
K190233K-Shield Advantage Port Access Infusion Set (PAIS)Kawasumi Laboratories, Inc.2019-05-02850
K172957Kawasumi Laboratories Blood Drawing Kit (BDK) SystemKawasumi Laboratories, Inc.2018-09-283670
K123344K-SHIELD ADVANTAGE PORT ACCESS INFUSION SET (PAIS)Kawasumi Laboratories, Inc.2013-03-071270
K100720K-SHIELD PORT ACCESS INFUSION SET WITH HIGH PRESSURE TUBINGKawasumi Laboratories, Inc.2010-11-182481
K102994K-SHIELD ARTERIAL VENOUS FISTULA SET WITH ANTINEEDLE STICK PKawasumi Laboratories, Inc.2010-11-03260
K073257KAWASUMI LABORATORIES LARGE WING SETS WITH ANTINEEDLE STICK Kawasumi Laboratories, Inc.2008-01-25670
K061197KAWASUMI LABORATORIES EMPTY SOLUTION CONTAINERKawasumi Laboratories, Inc.2006-06-30630
K060580K-SHIELD PORT ACCESS INFUSION SETKawasumi Laboratories, Inc.2006-06-06920
K023917WINGED NEEDLE SETS WITH AN ANTINEEDLE STICK PROTECTORKawasumi Laboratories, Inc.2003-02-26930
K022110KAWASUMI LABORATORIES ANTINEEDLE STICK PROTECTOR FOR USE WITKawasumi Laboratories, Inc.2002-09-12760

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