Atlas FDA

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

Delta Medical Industries · Predicate Candidate Screening

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

36 daysmedian FDA review time
214 days90th percentile
27clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K833884ISOTEC DISPOS. PRESSURE TRANSDUCERDelta Medical Industries1984-04-171600
K840253ONE-WAY AIR VALVEDelta Medical Industries1984-04-05730
K832470INFUSION PUMPDelta Medical Industries1984-02-282170
K830389ACCU-RYNGE PUMP SP-250Delta Medical Industries1983-09-122140
K831750PM-3Delta Medical Industries1983-07-26550
K822761DELIVERY TUBE SET #2226Delta Medical Industries1982-09-30160
K820912PMS-2 PRESSURE MONITOR SEPARATORDelta Medical Industries1982-05-18470
K820482ACCU-RYNGE INSULIN PUMP #SP-250Delta Medical Industries1982-03-26320
K810068PEDIATRIC ARTERIAL BLOOD FILTERDelta Medical Industries1981-01-2290
K802755ARTERIAL BLOOD FILTER BF-37Delta Medical Industries1981-01-07650
K803102ARTERIAL BUBBLE TRAP K-20Delta Medical Industries1980-12-22130
K803101PREBYPASS FILTER CAT.#K-5Delta Medical Industries1980-12-22130
K802602L-3 PURGE LINEDelta Medical Industries1980-11-12220
K801704OPEN-LOOP INSULIN DELIVERY SYSTEMDelta Medical Industries1980-08-13200
K801770ARTERIAL BUBBLE TRAPDelta Medical Industries1980-08-07100
K792182ICE CONTAINER I.C.E.Delta Medical Industries1979-11-15170
K790406DELTA D-750 THERMAFLOWDelta Medical Industries1979-11-132600
K790756HEAT EXCHANGER COILDelta Medical Industries1979-06-11550
K790116CARDIOTOMY RESERVOIR CR-2000Delta Medical Industries1979-02-08170
K781890CHAMBER, MC-1 DISPOSABLE PRESSUREDelta Medical Industries1978-12-04280
K781210HEAT EXCHANGER, FHX-14Delta Medical Industries1978-10-10850
K780485PREBYPASS FILTERDelta Medical Industries1978-04-0590
K771014TS-100 TEST SYSTEMDelta Medical Industries1977-06-1480
K770344SH-1Delta Medical Industries1977-05-09800
K770546BLOOD RESERVOIRDelta Medical Industries1977-04-26360
K760894VACUUM RELIEF VALVEDelta Medical Industries1976-12-09440
K760895AUTOMATIC SHUT-OFF VALVEDelta Medical Industries1976-12-09440

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