Atlas FDA

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

Neuwave Medical, Inc. · Predicate Candidate Screening

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

149 daysmedian FDA review time
303 days90th percentile
15clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K232227ABLATE-IQNeuwave Medical, Inc.2024-04-042520
K231738NEUWAVE™ Microwave Ablation System and AccessoriesNeuwave Medical, Inc.2023-11-161550
K220472NEUWAVE Microwave Ablation System and AccessoriesNeuwave Medical, Inc.2022-08-111740
K200081NEUWAVE Microwave Ablation System and AccessoriesNeuwave Medical, Inc.2020-11-133030
K192427Ablation ConfirmationNeuwave Medical, Inc.2019-10-03280
K173756Certus 140 2.45GHz Ablation SystemNeuwave Medical, Inc.2018-10-243170
K171022Ablation ConfirmationNeuwave Medical, Inc.2017-05-09340
K163118FLEX Microwave Ablation System and AccessoriesNeuwave Medical, Inc.2017-03-091210
K161285Ablation ConfirmationNeuwave Medical, Inc.2016-06-29510
K160936Certus 140 2.45GHz Ablation SystemNeuwave Medical, Inc.2016-05-04300
K150313Ablation ConfirmationNeuwave Medical, Inc.2015-07-091500
K130399CERTUS 140 CERTUSURGGT SURGICAL TOOLNeuwave Medical, Inc.2013-07-181490
K122217CERTUS 140 2.45GHZ ABLATION SYSTEMNeuwave Medical, Inc.2012-12-191470
K113237CERTUS 140 2.45GHZ ABLATION SYSTEMNeuwave Medical, Inc.2012-01-04630
K100744CERTUS 140 MICROWAVE ABLATION SYSTEM AND ACCESSORIES, MODEL Neuwave Medical, Inc.2010-10-222200

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