Delmed, Inc.: FDA clearances and approvals
Delmed, Inc. has 27 FDA 510(k) clearances (first 1979, latest 1990), across 11 product codes in 4 review panels. Median 510(k) review time: 114 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KNT | Tubes, Gastrointestinal (And Accessories) | 9 | 9 |
| KDJ | Set, Administration, For Peritoneal Dialysis, Disposable | 6 | 6 |
| FKX | System, Peritoneal, Automatic Delivery | 3 | 3 |
| KSR | Container, Empty, For Collection & Processing Of Blood & Blood Components | 2 | 2 |
| BTT | Humidifier, Respiratory Gas, (Direct Patient Interface) | 1 | 1 |
| FKK | Clamp, Line | 1 | 1 |
| FPA | Set, Administration, Intravascular | 1 | 1 |
| FRN | Pump, Infusion | 1 | 1 |
| KPE | Container, I.V. | 1 | 1 |
| KPO | Dialysate Concentrate For Hemodialysis (Liquid Or Powder) | 1 | 1 |
Plus 1 more product codes.
Review panels
- Gastroenterology and Urology (20)
- General Hospital (3)
- Hematology (2)
- Anesthesiology (1)
Most recent Delmed, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K895650 | ENTERAL PUMP SET W/ENTERA-FLO SPIKE | KNT | 1990-10-02 | 377 |
| K895329 | 600ML AND 1200ML ENTERAL BAG ADM. SET FOR ENTERA | KNT | 1990-10-02 | 397 |
| K895142 | ENTERAL PUMP SET WITH ENTERAL SPIKE | KNT | 1990-10-02 | 412 |
| K894506 | ENTERA-FLO ENTERAL FEEDING PUMP | FRN | 1990-08-06 | 383 |
| K901478 | DELMED 80/2 DIALYSIS SYSTEM W/LAST BAG OPTION | FKX | 1990-07-27 | 122 |
| K901477 | DELMED 80/2 DIALYSIS SYSTEM W/ULTRAFILTRATION | FKX | 1990-07-27 | 122 |
| K900106 | CLOSED DISCONNECT SYSTEM | KDJ | 1990-07-16 | 188 |
| K895933 | ENTERAL PUMP SETS FOR USE WITH ROSS FLEXIFLO-III | KNT | 1990-05-02 | 204 |
| K895919 | ENTERAL BAG ADMINI. SETS FOR USE W/FLEXIFLO-III | KNT | 1990-05-02 | 204 |
| K895696 | ENTERAL PUMP SET W/ENTERAL SPIKE FOR USE W/FEED PU | KNT | 1990-05-02 | 223 |
17 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Delmed, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of Delmed, Inc.'s product codes (a text match, not an official crosswalk):
- A4220 — Refill kit for implantable infusion pump (via FRN)
- E0786 — Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter) (via FRN)
- E0785 — Implantable intraspinal (epidural/intrathecal) catheter used with implantable infusion pump, replacement (via FRN)
Frequently asked questions
How many FDA 510(k) clearances does Delmed, Inc. have?
Delmed, Inc. has 27 FDA 510(k) clearances (first 1979, latest 1990), across 11 product codes in 4 review panels.
How long does FDA take to clear Delmed, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Delmed, Inc.'s cleared 510(k)s is 114 days.
What devices does Delmed, Inc. make?
Its most frequent FDA product codes are KNT (Tubes, Gastrointestinal (And Accessories), 9); KDJ (Set, Administration, For Peritoneal Dialysis, Disposable, 6); FKX (System, Peritoneal, Automatic Delivery, 3).
Has Delmed, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Delmed, Inc. Related entities may recall under other names.
Next steps
- See all 27 Delmed, Inc. clearances with predicates and recalls
- Run predicate analysis for product code KNT, Delmed, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.