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

Andover Medical, Inc. · Predicate Candidate Screening

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

43 daysmedian FDA review time
81 days90th percentile
21clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K905729CANMED 451Andover Medical, Inc.1991-02-07450
K903427NORTECH MODEL 86901000 ELECTRODEAndover Medical, Inc.1990-08-17170
K885171MODIFIED LABEL CHANGE TO MODEL 5455 SURGICAL CABLEAndover Medical, Inc.1989-01-12300
K860636FASTRACE III, ECG ELECTRODEAndover Medical, Inc.1986-05-09770
K854433ECG MONITORING/DEFIBRILLATION ELECTRODEAndover Medical, Inc.1986-05-081840
K860535UNILATERAL OXYGEN DELIVERY SYSTEM (ULODS)Andover Medical, Inc.1986-04-01480
K860283AMI CARDIO-PADAndover Medical, Inc.1986-03-31620
K843410FLOW-DIRECTED PEDIATRIC THERMODIL- CATHAndover Medical, Inc.1984-11-20810
K843412FLOW DIRECTED THERMODILUTION CATH W/VENAndover Medical, Inc.1984-11-20810
K843409FLOW-DIRECTED THERMODILUTION CATHAndover Medical, Inc.1984-10-18480
K843411THERMAL DILUTION CATHETERAndover Medical, Inc.1984-10-18480
K831785NEURO EASEAndover Medical, Inc.1983-06-30270
K823414HOLTER KIT MODEL #5000 SERIESAndover Medical, Inc.1982-12-30450
K822798DISPOSABLE ELECTRODE #1900Andover Medical, Inc.1982-10-15290
K812878THE NEW 1600 ELECTRODEAndover Medical, Inc.1981-11-02190
K812276DISPOSABLE ELECTRODE, #1610Andover Medical, Inc.1981-09-25430
K810271DIRECT CURRENT BONE GROWTH STIM. AN. PADAndover Medical, Inc.1981-02-19170
K790316ELECTRODE, ELECTROFLEXAndover Medical, Inc.1979-03-27400
K780908SELF-RETAINING ELECTRODE SER. #4000-100Andover Medical, Inc.1978-06-19140
K760280ELECTRODE SERIES 1401Andover Medical, Inc.1976-08-23310
K760358ELECTRODE SERIES 1600Andover Medical, Inc.1976-08-23210

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