Atlas FDA

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

Kendall Mcgaw Laboratories, Inc. · Predicate Candidate Screening

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

73 daysmedian FDA review time
138 days90th percentile
13clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K905610MICRORATE INTELLIGENT PUMPKendall Mcgaw Laboratories, Inc.1991-03-01800
K905611MICRORATE PLUS INTELLIGENT PUMPKendall Mcgaw Laboratories, Inc.1991-03-01800
K904855ADD-A-VIALKendall Mcgaw Laboratories, Inc.1990-11-19212
K904518VOLUMETRIC INFUSION PUMPKendall Mcgaw Laboratories, Inc.1990-10-171436
K903809PROTECTED NEEDLE WITH OR WITHOUT IV SETKendall Mcgaw Laboratories, Inc.1990-10-03440
K901065INFUSION PUMPKendall Mcgaw Laboratories, Inc.1990-08-211670
K900865ADD-A-VIAL II BINARY CONNECTORKendall Mcgaw Laboratories, Inc.1990-07-111382
K8962921.2 MICRON FILTER WITH IV SETKendall Mcgaw Laboratories, Inc.1989-12-08380
K895109SECONDARY IV SET WITH PROTECTED NEEDLEKendall Mcgaw Laboratories, Inc.1989-09-27430
K882159522 INTELLIGENT PUMPKendall Mcgaw Laboratories, Inc.1988-08-24930
K874467SET, ADMINISTRATION INTRAVASCULARKendall Mcgaw Laboratories, Inc.1988-01-06650
K862090MCGAW NUTRA-FEED EFS ENTERAL FEEDING BAGKendall Mcgaw Laboratories, Inc.1986-10-031230
K862091MCGAW NUTRA-FEED EFS ENTERAL FEEDING TUBEKendall Mcgaw Laboratories, Inc.1986-08-14730

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