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

Supelco, Inc. — Predicate Candidate Screening

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

36 daysmedian FDA review time
114 days90th percentile
24clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K894141LIQUID CHROMATOGRAPHY COLUMNSSupelco, Inc.1989-08-21690
K884403LIQUID CHROMATOGRAPHY COLUMNS SOLID PHASE EX. TUBESupelco, Inc.1988-12-22640
K883615LIQUID CHROMATOGRAPHY COLUMNS 5-7070/71/72/73Supelco, Inc.1988-12-161140
K881868LIQUID CHROMATOGRAPHY COLUMNS HISEP COLUMN & GUARDSupelco, Inc.1988-08-291180
K881361SOLID PHASE EXTRACTION TUBESSupelco, Inc.1988-08-081740
K880724LIQUID CHROMATO. COLUMNSSupelco, Inc.1988-05-27950
K874824CAPILLARY COLUMNS FOR GAS CHROMATOGRAPHYSupelco, Inc.1988-01-21580
K8711744-9295 BARBITURATES TEST MIXSupelco, Inc.1987-06-11790
K862542CAPILLARY COLUMNS FOR GAS CHROMATOGRAPHYSupelco, Inc.1986-08-04320
K862541LIQUID CHROMATOGRAPHY COLUMNSSupelco, Inc.1986-07-29260
K861633LIQUID CHROMATOGRAPHY COLUMNSSupelco, Inc.1986-05-23240
K842909LIQUID CHROMATOGRAPHY COLUMNS;ION EXCHSupelco, Inc.1984-10-05720
K841712CAPILLARY GAS CHROMATOGRAPHIC COLUMNSSupelco, Inc.1984-05-21270
K833276DRUG STANDARDSSupelco, Inc.1984-01-011010
K813575LIQUID CHROMATOGRAPHY (HPLC) COLUMNSSupelco, Inc.1982-01-18260
K811674DRUG STANDARDSSupelco, Inc.1981-07-15300
K811304LIQUID CHROMATOGRAPHY COLUMNSSupelco, Inc.1981-05-27160
K810743LECITHIN-SPINGOMYELIN STAND. & KITSSupelco, Inc.1981-03-31120
K810742AQUEOUS TRIOLEIN STANDARDS & KITSSupelco, Inc.1981-03-31120
K802278IN VITRO DIAGNOSTIC STANDARDSSupelco, Inc.1980-11-24730
K802703LIQUID CHROMATOGRAPHY COLUMNSSupelco, Inc.1980-11-12120
K801833GAS-CHROMATOGRAPHIC PACKINGSupelco, Inc.1980-08-27260
K761226GP3%SP-2100DOHON100/120 MESH SUPELCOPORTSupelco, Inc.1977-01-14360
K761156AMINOGLYCOSIDE CONTROLSSupelco, Inc.1976-12-09100

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