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

Life Sciences Manufacturing, Inc. — Predicate Candidate Screening

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

147 daysmedian FDA review time
193 days90th percentile
12clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K910905SFA-II MICROPROCESSOR-CONTROLLED MODULELife Sciences Manufacturing, Inc.1991-07-241410
K903700IPG-II MODULELife Sciences Manufacturing, Inc.1991-01-161540
K900365PAG MICROPROCESSOR-CONTROLLED MODULELife Sciences Manufacturing, Inc.1990-07-181740
K896500CWD/PPG MODULELife Sciences Manufacturing, Inc.1990-07-182460
K895588PORTABLE AIR PLETHYSMOGRAPHLife Sciences Manufacturing, Inc.1990-03-271930
K896528SFA MODULELife Sciences Manufacturing, Inc.1990-01-26710
K884624MVL/MODULAB WITH PVR MODULELife Sciences Manufacturing, Inc.1989-02-01890
K873041A-V RECORDERLife Sciences Manufacturing, Inc.1988-02-041840
K832679NON-INVASIVE CLINICAL VASCULAR LABLife Sciences Manufacturing, Inc.1984-01-031470
K822522CUTANEOUS PRESSURE PLETHYSMOGRAPHLife Sciences Manufacturing, Inc.1982-09-28360
K811560AUTOMATED PHYSIOLOGIC PROFILE MONITORLife Sciences Manufacturing, Inc.1981-06-18160
K791756VDCLife Sciences Manufacturing, Inc.1979-11-27830

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