Diatek, Inc.: FDA filings under this applicant name
FDA lists 15 510(k) clearances under the applicant name “Diatek, Inc.” (first 1979, latest 2002), across 7 product codes in 3 review panels. Median 510(k) review time under this name: 60 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 |
|---|---|---|---|
| FLL | Continuous Measurement Thermometer | 4 | 4 |
| FPA | Set, Administration, Intravascular | 4 | 4 |
| BSZ | Gas-Machine, Anesthesia | 2 | 2 |
| FRN | Pump, Infusion | 2 | 2 |
| BTO | Tube, Tracheostomy (W/Wo Connector) | 1 | 1 |
| MSD | Catheter, Hemodialysis, Implanted | 1 | 1 |
| NFK | Kit, Repair, Catheter, Hemodialysis | 1 | 1 |
Review panels
Most recent Diatek, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K020430 | DIATEK CONNECTOR ASSEMBLY REPLACEMENT KIT (CARK) | NFK | 2002-05-09 | 90 |
| K010399 | DIATEK CANNON-CATH #CC2400, CC2800, CC3200, CC3600,CC5500. CC2400PC, CC2800PC, CC3200PC(32 CM), CC3200PC(36 CM) | MSD | 2001-08-14 | 186 |
| K895703 | DIATEK MODEL 700 THERMOMETER | FLL | 1989-12-07 | 76 |
| K872178 | MODIFICATION TO ARKIVE(TM) | BSZ | 1988-01-27 | 233 |
| K862085 | ARKIVE (TM) | BSZ | 1987-01-12 | 224 |
| K841827 | ENTEROPORT NUTRITION PUMP | FRN | 1984-07-27 | 85 |
| K841859 | SECURA SET | FPA | 1984-07-03 | 60 |
| K833568 | DIATEK 600 THERMOMETER SYSTEM | FLL | 1984-01-10 | 90 |
| K830565 | SECURA SET SECONDARY ADMIN. SET | FPA | 1983-03-09 | 14 |
| K830377 | SECURA SET PRIMARY ADMIN. SET | FPA | 1983-03-01 | 25 |
5 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Diatek, 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 Diatek, 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)
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.
- Diatek Instruments, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Diatek, Inc.?
FDA lists 15 510(k) clearances under the applicant name “Diatek, Inc.” (first 1979, latest 2002), across 7 product codes in 3 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 Diatek, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Diatek, Inc. is 60 days.
Which FDA product codes appear under Diatek, Inc.?
The most frequent FDA product codes under this applicant name are FLL (Continuous Measurement Thermometer, 4); FPA (Set, Administration, Intravascular, 4); BSZ (Gas-Machine, Anesthesia, 2).
Next steps
- See all 15 Diatek, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FLL, Diatek, 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.