Atlas FDA

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

Acra Cut, Inc. · Predicate Candidate Screening

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

77 daysmedian FDA review time
139 days90th percentile
8clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K032970ACRA-CUT XPRESS 120Acra Cut, Inc.2003-12-08760
K944311ACRA-CUTAcra Cut, Inc.1994-11-18770
K911812ACRA-CUT WIRE PASS DRILLAcra Cut, Inc.1991-09-101390
K911819ACRA-CUT NEUROLOGICAL SURGICAL DEVICE-POWEREDAcra Cut, Inc.1991-09-101390
K910225BONE PAD REMOVERAcra Cut, Inc.1991-02-12250
K910226DURAL DISSECTORSAcra Cut, Inc.1991-02-12250
K892866AUTOMATIC CRANIAL DRILL (PERFORATOR)Acra Cut, Inc.1989-06-15570
K833266ACRA-CUTAcra Cut, Inc.1983-12-29990

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