Atlas FDA

Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

NHK — Predicate Candidate Screening

10 FDA 510(k) clearances under this product code; the 50 most recent screened below.

77 daysmedian FDA review time
151 days90th percentile
10clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K092687VENTI.PLUS HYPERINFLATION BAG SYSTEM WITH PRESSURE MANOMETERA Plus Medical2009-11-23830
K020281MODIFICATION TO VENTLAB HYPERINFLATION BAG SYSTEMVentlab Corp.2002-02-11140
K013308VENTLAB HYPERINFLATION BAG SYSTEMVentlab Corp.2001-12-20770
K001714MERCURY MEDICAL HYPERINFLATION BAG SYSTEM, MODEL 83-900-0149Mercury Medical2000-11-031510
K970785SIMS HYPERINFLATION BAG SYSTEMSims1997-06-131010
K952214SIMS INTERTECH HYPERINFLATION BAG SYSTEMIntertech Resources, Inc.1995-06-08280
K942571HYPER-INFLATION BAGMed-Plastics Intl., Inc.1994-06-10100
K940255HYPERINFLATION BAG SYSTEMNutec, Inc.1994-02-17290
K894612INTERTECH NEWBORN HYPERINFLATION BAG SYSTEMIntertech Resources, Inc.1989-09-08500
K813317DISP. HYPERINFLATION BAG SYSTEMIntec Medical, Inc.1982-03-121080

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