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

Pin Dot Products, Inc. — Predicate Candidate Screening

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

27 daysmedian FDA review time
47 days90th percentile
14clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K925258DYNAMIC PRESSURE MONITOR 2000M AND 2000CPin Dot Products, Inc.1993-03-091410
K913510MECHANICAL SHAPE SENSORPin Dot Products, Inc.1991-09-23470
K913548PIN DOT ALUMINUM PANPin Dot Products, Inc.1991-09-05270
K913511IMPALA AXLESPin Dot Products, Inc.1991-09-05290
K913507ARMRESTPin Dot Products, Inc.1991-09-05290
K913553PIN DOT GROWTH/DIAL LINKSPin Dot Products, Inc.1991-09-05270
K913550PIN DOT TRUNION MOUNTSPin Dot Products, Inc.1991-09-05270
K913549PIN DOT MOUNTING BRACKETSPin Dot Products, Inc.1991-09-05270
K913545PIN DOT FLIP-DOWN ABDUCTORPin Dot Products, Inc.1991-09-05270
K913546IMPALA CASTERSPin Dot Products, Inc.1991-09-05270
K913509IMPALA WHEELSPin Dot Products, Inc.1991-09-05290
K913512IMPALAPin Dot Products, Inc.1991-08-29220
K913544DUKKIPin Dot Products, Inc.1991-08-29200
K913552PIN DOT FOOTREST PRODUCTSPin Dot Products, Inc.1991-08-29200

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