Hemocleanse, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Hemocleanse, Inc.” (first 1994, latest 1999), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 189 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 |
|---|---|---|---|
| FLD | Apparatus, Hemoperfusion, Sorbent | 3 | 3 |
| KNT | Tubes, Gastrointestinal (And Accessories) | 1 | 1 |
| MLW | Warmer, Peritoneal Dialysate | 1 | 1 |
Review panels
Most recent Hemocleanse, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K993330 | THERMOCHEM-HT SYSTEM | MLW | 1999-12-30 | 87 |
| K992196 | BIOLOGIC-DT SYSTEM (BIOLOGIC-DT-1000 WITH DT-1000-TK) | FLD | 1999-09-10 | 72 |
| K984546 | BIOLOGIC-DT MACHINE, MODEL DT-1000 AND BIOLOGIC-DT TREATMENT KIT, MODEL DT-1000-TK | FLD | 1999-08-13 | 234 |
| K953751 | BIOLOGIC-DT SYSTEM | FLD | 1996-02-15 | 189 |
| K923046 | BIOLOGIC DT-1000 MACHINE | KNT | 1994-09-30 | 828 |
Recalls
openFDA lists no recalls under a recalling firm named Hemocleanse, 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Hemocleanse, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Hemocleanse, Inc.” (first 1994, latest 1999), 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 Hemocleanse, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Hemocleanse, Inc. is 189 days.
Which FDA product codes appear under Hemocleanse, Inc.?
The most frequent FDA product codes under this applicant name are FLD (Apparatus, Hemoperfusion, Sorbent, 3); KNT (Tubes, Gastrointestinal (And Accessories), 1); MLW (Warmer, Peritoneal Dialysate, 1).
Next steps
- See all 5 Hemocleanse, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FLD, Hemocleanse, 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.