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

Delmed, Inc. · Predicate Candidate Screening

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

114 daysmedian FDA review time
383 days90th percentile
27clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K895329600ML AND 1200ML ENTERAL BAG ADM. SET FOR ENTERADelmed, Inc.1990-10-023970
K895650ENTERAL PUMP SET W/ENTERA-FLO SPIKEDelmed, Inc.1990-10-023770
K895142ENTERAL PUMP SET WITH ENTERAL SPIKEDelmed, Inc.1990-10-024120
K894506ENTERA-FLO ENTERAL FEEDING PUMPDelmed, Inc.1990-08-063830
K901478DELMED 80/2 DIALYSIS SYSTEM W/LAST BAG OPTIONDelmed, Inc.1990-07-271220
K901477DELMED 80/2 DIALYSIS SYSTEM W/ULTRAFILTRATIONDelmed, Inc.1990-07-271220
K900106CLOSED DISCONNECT SYSTEMDelmed, Inc.1990-07-161880
K895696ENTERAL PUMP SET W/ENTERAL SPIKE FOR USE W/FEED PUDelmed, Inc.1990-05-022230
K895246FRENTA(R) DUO-SETDelmed, Inc.1990-05-022540
K895330600ML AND 1200ML ENTERAL BAG ADM. SET FOR FRENTADelmed, Inc.1990-05-022440
K895919ENTERAL BAG ADMINI. SETS FOR USE W/FLEXIFLO-IIIDelmed, Inc.1990-05-022040
K895933ENTERAL PUMP SETS FOR USE WITH ROSS FLEXIFLO-IIIDelmed, Inc.1990-05-022040
K893209ENTERA-FLO SPIKE SETDelmed, Inc.1989-07-24880
K893712PERITONEAL DIALYSIS SYSTEM AND ACCESS.Delmed, Inc.1989-07-24670
K893231DELCLAMPDelmed, Inc.1989-06-08410
K881184INTERTECH STERILE WATER FOR INHALATIONDelmed, Inc.1988-05-25650
K872857HOSPAL DIALYSATE FOR C.A.V.H.D.Delmed, Inc.1987-10-05760
K871155DELFLEX RIGID DRAIN CONTAINERDelmed, Inc.1987-07-161140
K870626FREEDOM SET II WITH TRIFLEX VALVEDelmed, Inc.1987-06-031100
K871154DELFLEX SAFE LOCK CAPD PATIENT ASSIST DEVICEDelmed, Inc.1987-04-30370
K831689EMPTY DIALYSATE CONTAINERDelmed, Inc.1983-08-11790
K830689EMPTY DIALYSATE CONTAINER BB-69Delmed, Inc.1983-03-29420
K830450DELMED IV CONTAINERDelmed, Inc.1983-03-01140
K810500BLOOD FREEZING BAGDelmed, Inc.1981-09-232110
K802671EMPTY TRANSFER BAGSDelmed, Inc.1980-10-2700
K791672ALBUMIN INTRAVENOUS ADMINISTRATION SETDelmed, Inc.1979-10-26590
K791673EMPTY TRANSFER BAGDelmed, Inc.1979-10-23560

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