Emed Technologies Corporation: FDA filings under this applicant name
FDA lists 11 510(k) clearances under the applicant name “Emed Technologies Corporation” (first 2012, latest 2025), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 142 days. Since 2017 the median was 249 days, against 232 days for all cleared 510(k)s in the same product codes. 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 | 1 | 16 |
| 2013 | 0 | — |
| 2014 | 2 | 97 |
| 2015 | 1 | 267 |
| 2016 | 1 | 142 |
| 2017 | 0 | — |
| 2018 | 1 | 366 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 2 | 227 |
| 2023 | 1 | 243 |
| 2024 | 1 | 28 |
| 2025 | 1 | 255 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Emed Technologies Corporation took a median 249 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 232 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| PKP | Immunoglobulin G (Igg) Infusion System | 7 | 7 |
| FPA | Set, Administration, Intravascular | 3 | 3 |
| KZH | Introducer, Syringe Needle | 1 | 1 |
Review panels
- General Hospital (11)
Most recent Emed Technologies Corporation 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K251105 | Tetra (TM-20); Tetra (TM-50) | PKP | 2025-12-22 | 255 |
| K240148 | SCIg60 Infusion System | PKP | 2024-02-16 | 28 |
| K230883 | VersaPump Infusion System | PKP | 2023-11-28 | 243 |
| K213429 | AccuSert Needle Inserter | KZH | 2022-10-20 | 364 |
| K222087 | SCIg60 Infusion System | PKP | 2022-10-13 | 90 |
| K173783 | SCIg60 Infusion System | PKP | 2018-12-14 | 366 |
| K161906 | SCIg60 Infuser | PKP | 2016-12-01 | 142 |
| K142319 | SCIg60 Infuser, Infuset | PKP | 2015-05-14 | 267 |
| K140133 | INFUSET FLOW CONTROL EXTENSION SET | FPA | 2014-05-15 | 118 |
| K140131 | SUB-Q SUBCUTANEOUS TISSUE INFUSION SET | FPA | 2014-04-03 | 76 |
1 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Emed Technologies Corporation.
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.
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.
- Emed, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Emed Technologies Corporation?
FDA lists 11 510(k) clearances under the applicant name “Emed Technologies Corporation” (first 2012, latest 2025), across 3 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Emed Technologies Corporation?
The median time from FDA receipt to decision across 510(k)s cleared under the name Emed Technologies Corporation is 142 days. Since 2017: 249 days, versus 232 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Emed Technologies Corporation?
The most frequent FDA product codes under this applicant name are PKP (Immunoglobulin G (Igg) Infusion System, 7); FPA (Set, Administration, Intravascular, 3); KZH (Introducer, Syringe Needle, 1).
Next steps
- See all 11 Emed Technologies Corporation clearances with predicates and recalls
- Run predicate analysis for product code PKP, Emed Technologies Corporation'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.