Atlas FDA

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

Berman, Pcp & Consultants, Inc. · Predicate Candidate Screening

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

84 daysmedian FDA review time
84 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K771983SCALP VEIN SETBerman, Pcp & Consultants, Inc.1978-01-05790
K771270BLOOD ADMINISTRATION TYPE RBerman, Pcp & Consultants, Inc.1977-09-12840
K771267INFUSION SET TYPE SBerman, Pcp & Consultants, Inc.1977-09-12840
K771268INFUSION SET TYPE JBerman, Pcp & Consultants, Inc.1977-09-12840
K771272DISP. SYRINGES: 2,5 & L0 MI.Berman, Pcp & Consultants, Inc.1977-09-12840
K771271SCALP VEIN SETBerman, Pcp & Consultants, Inc.1977-09-12840
K771269BLOOD COLLECTION SET TYPE HBerman, Pcp & Consultants, Inc.1977-09-12840

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