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Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

Kentron Health Care, Inc. · Predicate Candidate Screening

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

119 daysmedian FDA review time
175 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K030693KENTEX DISPOSABLE VAGINAL SPECULUMKentron Health Care, Inc.2003-08-271750
K971917KENTRON'S ISOLATION GOWNKentron Health Care, Inc.1997-09-191190
K972410IMPERVIOUS ISOLATION GOWNKentron Health Care, Inc.1997-09-19850
K953465KENTEMPKentron Health Care, Inc.1995-12-151440
K953914KENTEXKentron Health Care, Inc.1995-11-06770
K953830KENSORBKentron Health Care, Inc.1995-10-03480

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