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

Biopsys Medical, Inc. · Predicate Candidate Screening

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

38 daysmedian FDA review time
143 days90th percentile
15clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K970817MICROMARK CLIPBiopsys Medical, Inc.1997-09-111890
K970565MAMMOTOME BIOPSY PROBE AND HOUSING (MAMMOTOME)Biopsys Medical, Inc.1997-03-28430
K963015SURGICAL STAPLE MARKER DEVICE (MODIFY)Biopsys Medical, Inc.1996-10-07740
K960019RETRACTOR ARM CLAMPBiopsys Medical, Inc.1996-02-09380
K953880BIOPSY NEEDLEBiopsys Medical, Inc.1995-09-08210
K953962FORCEPSBiopsys Medical, Inc.1995-09-08170
K951326BIOPSY DEVICE ACCESSORYBiopsys Medical, Inc.1995-05-15530
K951229MODIFIED BIOPSY NEEDLEBiopsys Medical, Inc.1995-04-06170
K950006SURGICAL STAPLE MARKERBiopsys Medical, Inc.1995-03-15710
K943863NEEDLE GUIDEBiopsys Medical, Inc.1994-12-291430
K945573BIOPSY DEVICE ACCESSORYBiopsys Medical, Inc.1994-12-09250
K944252BIOPSY DEVICE ACCESSORYBiopsys Medical, Inc.1994-12-05970
K945133MODIFIED BIOPSY NEEDLEBiopsys Medical, Inc.1994-11-09200
K942639BIOPSY NEEDLE AND HOUSINGBiopsys Medical, Inc.1994-07-07340
K941549BIOPSY NEEDLE AND HOUSINGBiopsys Medical, Inc.1994-04-19200

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