Delmed, Inc.
US
Delmed, Inc. appears in FDA device records in US. FDA records list 27 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 27
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 27 510(k) clearances for Delmed, Inc. between 1979 and 1990. The busiest year on record is 1990, with 12. The most recent is 1990, with 12.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1979 | 2 |
| 1980 | 1 |
| 1981 | 1 |
| 1983 | 3 |
| 1987 | 4 |
| 1988 | 1 |
| 1989 | 3 |
| 1990 | 12 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K895650 | ENTERAL PUMP SET W/ENTERA-FLO SPIKE | KNT | Substantially Equivalent | |
| K895329 | 600ML AND 1200ML ENTERAL BAG ADM. SET FOR ENTERA | KNT | Substantially Equivalent | |
| K895142 | ENTERAL PUMP SET WITH ENTERAL SPIKE | KNT | Substantially Equivalent | |
| K894506 | ENTERA-FLO ENTERAL FEEDING PUMP | FRN | Substantially Equivalent | |
| K901478 | DELMED 80/2 DIALYSIS SYSTEM W/LAST BAG OPTION | FKX | Substantially Equivalent | |
| K901477 | DELMED 80/2 DIALYSIS SYSTEM W/ULTRAFILTRATION | FKX | Substantially Equivalent | |
| K900106 | CLOSED DISCONNECT SYSTEM | KDJ | Substantially Equivalent | |
| K895933 | ENTERAL PUMP SETS FOR USE WITH ROSS FLEXIFLO-III | KNT | Substantially Equivalent | |
| K895919 | ENTERAL BAG ADMINI. SETS FOR USE W/FLEXIFLO-III | KNT | Substantially Equivalent | |
| K895696 | ENTERAL PUMP SET W/ENTERAL SPIKE FOR USE W/FEED PU | KNT | Substantially Equivalent | |
| K895330 | 600ML AND 1200ML ENTERAL BAG ADM. SET FOR FRENTA | KNT | Substantially Equivalent | |
| K895246 | FRENTA(R) DUO-SET | KNT | Substantially Equivalent | |
| K893712 | PERITONEAL DIALYSIS SYSTEM AND ACCESS. | KDJ | Substantially Equivalent | |
| K893209 | ENTERA-FLO SPIKE SET | KNT | Substantially Equivalent | |
| K893231 | DELCLAMP | KDJ | Substantially Equivalent | |
| K881184 | INTERTECH STERILE WATER FOR INHALATION | BTT | Substantially Equivalent | |
| K872857 | HOSPAL DIALYSATE FOR C.A.V.H.D. | KPO | Substantially Equivalent | |
| K871155 | DELFLEX RIGID DRAIN CONTAINER | KDJ | Substantially Equivalent | |
| K870626 | FREEDOM SET II WITH TRIFLEX VALVE | KDJ | Substantially Equivalent | |
| K871154 | DELFLEX SAFE LOCK CAPD PATIENT ASSIST DEVICE | KDJ | Substantially Equivalent | |
| K831689 | EMPTY DIALYSATE CONTAINER | FKK | Substantially Equivalent | |
| K830689 | EMPTY DIALYSATE CONTAINER BB-69 | FKX | Substantially Equivalent | |
| K830450 | DELMED IV CONTAINER | KPE | Substantially Equivalent | |
| K810500 | BLOOD FREEZING BAG | KSR | Substantially Equivalent | |
| K802671 | EMPTY TRANSFER BAGS | Unknown | ||
| K791672 | ALBUMIN INTRAVENOUS ADMINISTRATION SET | FPA | Substantially Equivalent | |
| K791673 | EMPTY TRANSFER BAG | KSR | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- FKKClamp, Line
- KSRContainer, Empty, For Collection & Processing Of Blood & Blood Components
- KPEContainer, I.V.
- KPODialysate Concentrate For Hemodialysis (Liquid Or Powder)
- BTTHumidifier, Respiratory Gas, (Direct Patient Interface)
- FRNPump, Infusion
- KDJSet, Administration, For Peritoneal Dialysis, Disposable
- FPASet, Administration, Intravascular
- FKXSystem, Peritoneal, Automatic Delivery
- KNTTubes, Gastrointestinal (And Accessories)
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
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Data as of , FDA export datePage updated Source: openFDA, public domain