Atlas FDA

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

Fidelity Medical, Inc. · Predicate Candidate Screening

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

311 daysmedian FDA review time
374 days90th percentile
8clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K983088INSTACINE D-2000Fidelity Medical, Inc.1998-09-22250
K942558INSTACINEFidelity Medical, Inc.1995-05-303640
K942504INSTASPOTFidelity Medical, Inc.1995-05-053440
K941917FLUOROPLUA CARDIAC AND/OR INSTAVIEWFidelity Medical, Inc.1995-02-243110
K903774LP-PLUSFidelity Medical, Inc.1991-08-293740
K872928LP-3000 HIGH RESOLUTION ELECTROCARDIOGRAPHFidelity Medical, Inc.1988-01-061630
K864614LP-3 ELECTROCARDIOGRAPHFidelity Medical, Inc.1987-06-162040
K841780CLINICAL ELECTRONIC THERMOMETERFidelity Medical, Inc.1984-07-06670

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