Atlas FDA

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

Carl Parker Associates, Inc. · Predicate Candidate Screening

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

91 daysmedian FDA review time
441 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K971130DEFEND FLUID RESISTANT PLEATED MASKCarl Parker Associates, Inc.1997-06-27920
K962654COMPLEAT SURGICAL MASKCarl Parker Associates, Inc.1997-01-272030
K932056DEFEND SELF-SEALING STERILIZATION POUCHCarl Parker Associates, Inc.1994-07-134410
K891308STERILE SURGICAL GLOVESCarl Parker Associates, Inc.1989-04-26480
K891257DEFEND LATEX EXAMINATION GLOVESCarl Parker Associates, Inc.1989-03-22140
K891157DEFEND LATEX EXAMINATION GLOVESCarl Parker Associates, Inc.1989-03-16100
K871558DENTAL FACE MASKS, POLYESTERCarl Parker Associates, Inc.1987-07-22910

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