Extracorporeal Medical Specialities, Inc.: FDA filings under this applicant name
FDA lists 69 510(k) clearances under the applicant name “Extracorporeal Medical Specialities, Inc.” (first 1976, latest 1984), across 33 product codes in 4 review panels. Median 510(k) review time under this name: 43 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 |
|---|---|---|---|
| KOC | Accessories, Blood Circuit, Hemodialysis | 11 | 11 |
| FJK | Set, Tubing, Blood, With And Without Anti-Regurgitation Valve | 6 | 6 |
| FJG | Dialyzer, Parallel Flow | 4 | 4 |
| FKP | System, Dialysate Delivery, Single Patient | 4 | 4 |
| FKQ | System, Dialysate Delivery, Central Multiple Patient | 4 | 4 |
| DTM | Filter, Blood, Cardiopulmonary Bypass, Arterial Line | 3 | 3 |
| DTZ | Oxygenator, Cardiopulmonary Bypass | 3 | 3 |
| FJI | Dialyzer, Capillary, Hollow Fiber | 3 | 3 |
| BTR | Tube, Tracheal (W/Wo Connector) | 2 | 2 |
| DTN | Reservoir, Blood, Cardiopulmonary Bypass | 2 | 2 |
Plus 23 more product codes.
Review panels
- Gastroenterology and Urology (46)
- Cardiovascular (15)
- Anesthesiology (3)
- General Hospital (2)
Most recent Extracorporeal Medical Specialities, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K843955 | EXTRACORPOREAL MAXIMA HOLLOW FIBER OXYGENATOR | DTZ | 1984-11-29 | 51 |
| K840532 | HEMOPERFUSION SYSTEM TP-400 | FLD | 1984-05-30 | 119 |
| K840262 | HANCOCK PERICARDIAL PATCH | DXZ | 1984-05-30 | 132 |
| K840146 | EXP* 700 PARALLEL PLATE DIALYZER | KOC | 1984-02-04 | 22 |
| K840057 | EXP* 500 PARALLEL PLATE DIALYZER | KOC | 1984-02-04 | 26 |
| K832547 | ULTRAFILTRATION CONTROLLER | KDI | 1984-01-03 | 155 |
| K831423 | THERAPEUTIC EXCHANGE SYSTEM | LQQ | 1984-01-03 | 245 |
| K833477 | INTERSEPT 40 MICRON FILTER | DTM | 1983-12-27 | 81 |
| K833476 | INTERSEPT 40 MICRON FILTER W/TUBING | DTM | 1983-12-27 | 81 |
| K831424 | THERAPEUTIC EXCHANGE BLOOD TUBING-TP-101 | FJK | 1983-10-14 | 164 |
59 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Extracorporeal Medical Specialities, Inc..
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 Extracorporeal Medical Specialities, Inc. (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 are listed under Extracorporeal Medical Specialities, Inc.?
FDA lists 69 510(k) clearances under the applicant name “Extracorporeal Medical Specialities, Inc.” (first 1976, latest 1984), across 33 product codes in 4 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 Extracorporeal Medical Specialities, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Extracorporeal Medical Specialities, Inc. is 43 days.
Which FDA product codes appear under Extracorporeal Medical Specialities, Inc.?
The most frequent FDA product codes under this applicant name are KOC (Accessories, Blood Circuit, Hemodialysis, 11); FJK (Set, Tubing, Blood, With And Without Anti-Regurgitation Valve, 6); FJG (Dialyzer, Parallel Flow, 4).
Next steps
- See all 69 Extracorporeal Medical Specialities, Inc. clearances with predicates and recalls
- Run predicate analysis for product code KOC, Extracorporeal Medical Specialities, Inc.'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.