Atlas FDA

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

Pfizer Medical Systems, Inc. · Predicate Candidate Screening

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

52 daysmedian FDA review time
63 days90th percentile
12clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K803032PFIZER PZ-SLM RAD. THERAPY TRTMT. SIMUL.Pfizer Medical Systems, Inc.1981-01-22520
K802531PFIZONIC 200 ULTRASOUND SCANNERPfizer Medical Systems, Inc.1980-12-18630
K802529PFIZONIC 100 ULTRASOUND SCANNERPfizer Medical Systems, Inc.1980-12-18630
K802530PFIZONIC 250 ULTRASOUND SCANNERPfizer Medical Systems, Inc.1980-12-18630
K802528PFIZONIC 150 ULTRASOUND SCANNERPfizer Medical Systems, Inc.1980-12-18630
K802532PFIZONIC 300 ULTRASOUND SCANNERPfizer Medical Systems, Inc.1980-12-18630
K801446PFIZER PZ-CT SCANNERPfizer Medical Systems, Inc.1980-07-28380
K800501PFIZER/AS&E 0450 LOCALIZERPfizer Medical Systems, Inc.1980-04-10370
K781752SCANNER, CT 0450Pfizer Medical Systems, Inc.1978-11-03160
K780278RADIATION THERAPY TREAT. PLAN. SYS.Pfizer Medical Systems, Inc.1978-03-02130
K772289SCANNER, CT, 0400Pfizer Medical Systems, Inc.1977-12-2190
K770573ACTA-SCANNER R 0200FSPfizer Medical Systems, Inc.1977-03-3050

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