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

Continental Medical Laboratories, Inc. · Predicate Candidate Screening

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

74 daysmedian FDA review time
346 days90th percentile
8clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K964827PROD. NO. 01-132 - SUTURE REMOVAL KITContinental Medical Laboratories, Inc.1997-02-14740
K963234STAPLE REMOVAL KITContinental Medical Laboratories, Inc.1996-10-21630
K963443PROD. NO. 02-031 - LACERATION TRAYContinental Medical Laboratories, Inc.1996-10-17480
K962078TRACHEOSTOMY CLEANING TRAY W/SUCTION CATHETERContinental Medical Laboratories, Inc.1996-10-111360
K954728PROD NO. 01-1694 - 4X4 FOAM DRESSINGContinental Medical Laboratories, Inc.1996-09-233460
K962073URETHRAL CATHETERIZATION TRAY/UNIVERSAL URETHRAL CATH TRAYContinental Medical Laboratories, Inc.1996-06-21240
K952335WOUND CARE MANAGEMENT KITSContinental Medical Laboratories, Inc.1995-06-14270
K905123G-TUBE DRESSING CHANGE TRAYContinental Medical Laboratories, Inc.1991-03-271330

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