Atlas FDA

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

Mcneil Healthcare, Inc. · Predicate Candidate Screening

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

32 daysmedian FDA review time
53 days90th percentile
19clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K935883NEUROLOGICAL SPONGESMcneil Healthcare, Inc.1994-02-03560
K935930NON ADHERENT DRESSING AND NON ADHERENT DRAIN DRESSINGMcneil Healthcare, Inc.1994-02-03520
K935993SURGICAL SPONGE X-RAY DETECTABLEMcneil Healthcare, Inc.1994-02-02510
K935881SPECIALTY SPONGESMcneil Healthcare, Inc.1994-01-31530
K935882TONSIL SPONGESMcneil Healthcare, Inc.1994-01-31530
K935910X-RAY PACKING SPONGEMcneil Healthcare, Inc.1994-01-31530
K935911PACKING SPONGEMcneil Healthcare, Inc.1994-01-31530
K935934NON ADHERANT BURN PADSMcneil Healthcare, Inc.1994-01-31490
K935931NON-WOVEN SPONGEMcneil Healthcare, Inc.1994-01-14320
K935932BURN COMPRESSMcneil Healthcare, Inc.1994-01-14320
K935933CUSTOM BURN DRESSINGMcneil Healthcare, Inc.1994-01-14320
K935935BURN GAUZE PADSMcneil Healthcare, Inc.1994-01-14320
K935936CONFORMING ROLLMcneil Healthcare, Inc.1994-01-14320
K935937POST OP SPONGEMcneil Healthcare, Inc.1994-01-14320
K935938BANDAGE ROLLS, STRETCH GAUZE ROLLS, TEXTURED GAUZE ROLLSMcneil Healthcare, Inc.1994-01-14320
K935939GAUZE FLUFFMcneil Healthcare, Inc.1994-01-14320
K935940GAUZE SPONGE; DRAIN SPONGEMcneil Healthcare, Inc.1994-01-14320
K935941READY CUT GAUZE GAUZE BOLTSMcneil Healthcare, Inc.1994-01-14320
K935942SURGICAL LAPAROTOMY SPONGE X-RAY DETECTABLEMcneil Healthcare, Inc.1994-01-13310

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