Atlas FDA

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

Seamed Corp. — Predicate Candidate Screening

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

80 daysmedian FDA review time
194 days90th percentile
18clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K923398CPI MODEL 2215Seamed Corp.1992-08-14350
K915364CHRONOCOR VI MODEL 5012Seamed Corp.1992-02-07720
K912507CPI MODEL 2215 & SEAMED MODEL 3400Seamed Corp.1991-09-03890
K910223CPI MODEL 2215/SEAMED MODEL 3400Seamed Corp.1991-03-19600
K883930SEAMED MODEL 3300 DUAL CHAMBER PACING SYSTEM ANALYSeamed Corp.1988-11-09550
K872551SEAMED MODEL 3200Seamed Corp.1987-07-31320
K863903SEA MED MODEL 6000Seamed Corp.1986-12-10640
K860462SEAMED MODEL 3000Seamed Corp.1986-08-191940
K854648SEAMED MODEL 4000Seamed Corp.1986-01-16580
K852746EXTERNAL PACEMAKER TELECTRONICS TE200Seamed Corp.1985-09-12770
K851900SEA MED DDD PACING SYSTEM ANALYZERSeamed Corp.1985-07-19800
K850822CHRONOCOR V EXTERNAL PACER, MODEL 297ASeamed Corp.1985-07-161380
K843807SEAMED MODEL 6000Seamed Corp.1985-02-011270
K843777SEAMED 4000Seamed Corp.1985-02-011290
K831697TELECTRONICS MODEL 2401Seamed Corp.1984-09-044680
K831381RAPID ATRIAL PACERSeamed Corp.1983-08-311250
K823048SEA MED MODEL 880Seamed Corp.1982-12-15610
K820570SEAMED, #540 - SIEMENS, #146F TELECTROSeamed Corp.1982-06-03930

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