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

Coratomic, Inc. — Predicate Candidate Screening

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

52 daysmedian FDA review time
117 days90th percentile
15clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K863365MODIFICATION OF STERILITY CYCLE PARAMETERSCoratomic, Inc.1986-10-08360
K822791CORATOMIC #VX5-105 & VX5-205 PULSE GEN.Coratomic, Inc.1982-12-15910
K820939C-101-PCoratomic, Inc.1982-06-22770
K821033CORATOMIC MODEL OVALITH-920Coratomic, Inc.1982-05-28450
K821014CORATOMIC MODEL OVALITH 920BPCoratomic, Inc.1982-05-28460
K810808CORATOMIC MODEL OVALITH-920Coratomic, Inc.1981-05-15520
K802689L-15T ENDOCARDIAL PACING ELECTRODECoratomic, Inc.1980-10-2800
K800194OVALITH P-BP BIPOLAR CARDIAC PACEMAKERCoratomic, Inc.1980-02-11130
K790446OVALITH-300Coratomic, Inc.1979-07-301580
K781377OVALITH 10BPCoratomic, Inc.1978-12-041170
K780569L-12, L-21, AND L-22 ELECTRODESCoratomic, Inc.1978-06-14640
K772309ENDOCARDIAL PACING ELECTRODECoratomic, Inc.1978-02-06590
K771992L-501 CARDIAC PACEMAKERCoratomic, Inc.1977-11-02120
K770559C-L0L CARDIAC PACEMAKERCoratomic, Inc.1977-03-2850
K760714ENDO-LOK L-40 ENDOCARDIAL PACING ELECT.Coratomic, Inc.1976-12-14800

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