Imed Corp.: FDA filings under this applicant name
FDA lists 43 510(k) clearances under the applicant name “Imed Corp.” (first 1977, latest 1996), across 7 product codes in 2 review panels. Median 510(k) review time under this name: 78 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
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 |
|---|---|---|---|
| FRN | Pump, Infusion | 22 | 22 |
| FPA | Set, Administration, Intravascular | 12 | 12 |
| FLN | Monitor, Electric For Gravity Flow Infusion Systems | 4 | 4 |
| FPB | Filter, Infusion Line | 2 | 2 |
| BWB | Forceps, Tube Introduction | 1 | 1 |
| LDR | Controller, Infusion, Intravascular, Electronic | 1 | 1 |
| MEB | Pump, Infusion, Elastomeric | 1 | 1 |
Review panels
- General Hospital (42)
- Anesthesiology (1)
Most recent Imed Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K960512 | GEMINI PC-ITX | FRN | 1996-11-21 | 290 |
| K953896 | THE IMED AMBULATORY INFUSION PUMP, ADMINISTRATION SETS | FRN | 1996-03-20 | 216 |
| K950153 | VENTED/NONVENTED GEMINI ADMINISTRATION SET WITH CHECK VALVE AND TWO SAFSITE(TM) VALVES | FPA | 1995-08-24 | 219 |
| K951922 | ADMINISTRATION SETS WITH BALL FLOAT | FPA | 1995-07-19 | 86 |
| K950419 | THE IMED ORION INFUSION PUMP AND ADMINISTRATION SETS | FRN | 1995-06-21 | 141 |
| K944320 | VENTED/NON-VENTED GEMINI ADMINISTRATION SET | FPA | 1995-02-14 | 169 |
| K945070 | VERSASAE PLASTIC CANNULA- 11 GAUGE | FPA | 1995-01-13 | 91 |
| K931173 | PRIMARY ADMIN SET W/UNIV SP-MAN BELOW/ABV PUMP CH | FPA | 1994-04-15 | 403 |
| K933144 | GEMINI VOLUMETRIC INFUSION PUMP/CONTROLLER | FRN | 1993-10-12 | 106 |
| K924718 | SHROUDED NEEDLE DEVICES | FPA | 1993-06-18 | 270 |
33 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Imed Corp..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Imed Corp. (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)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Imed Technology, Inc. (2 510(k)s)
- Imed Ireland, Ltd. (1 510(k)s)
- Imed Systems & Consulting, LLC (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Imed Corp.?
FDA lists 43 510(k) clearances under the applicant name “Imed Corp.” (first 1977, latest 1996), across 7 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Imed Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Imed Corp. is 78 days.
Which FDA product codes appear under Imed Corp.?
The most frequent FDA product codes under this applicant name are FRN (Pump, Infusion, 22); FPA (Set, Administration, Intravascular, 12); FLN (Monitor, Electric For Gravity Flow Infusion Systems, 4).
Next steps
- See all 43 Imed Corp. clearances with predicates and recalls
- Run predicate analysis for product code FRN, Imed Corp.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.