Healthtek, Inc.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Healthtek, Inc.” (first 1985, latest 1993), across 5 product codes in 2 review panels. Median 510(k) review time under this name: 107 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 |
|---|---|---|---|
| LHI | Set, I.V. Fluid Transfer | 4 | 4 |
| KPE | Container, I.V. | 2 | 2 |
| FPB | Filter, Infusion Line | 1 | 1 |
| FRN | Pump, Infusion | 1 | 1 |
| GDM | Needle, Aspiration And Injection, Reusable | 1 | 1 |
Review panels
Most recent Healthtek, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K923448 | EMPTY SOLUTION TRANSFER CONTAINER W/ DETACH LEG | KPE | 1993-07-28 | 379 |
| K913985 | TRANSFER-AID(TM) | LHI | 1992-03-18 | 195 |
| K913608 | SNAPPER | KPE | 1991-11-29 | 107 |
| K881590 | ADFUSE(TM) | FRN | 1988-05-23 | 40 |
| K874495 | ADCOMP 4000 HP SYSTEM | LHI | 1988-02-16 | 106 |
| K873848 | RETROBULBAR NEEDLE | GDM | 1987-10-23 | 31 |
| K860610 | ADCOMP | LHI | 1986-07-08 | 139 |
| K860372 | FAST FLOW XX (AQUEOUS SOLUTION FILTER) | FPB | 1986-05-30 | 116 |
| K854008 | STATLOCK | LHI | 1985-11-13 | 44 |
Recalls
openFDA lists no recalls under a recalling firm named Healthtek, 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 Healthtek, 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.
- Healthtek Microsurgical, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Healthtek, Inc.?
FDA lists 9 510(k) clearances under the applicant name “Healthtek, Inc.” (first 1985, latest 1993), across 5 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 Healthtek, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Healthtek, Inc. is 107 days.
Which FDA product codes appear under Healthtek, Inc.?
The most frequent FDA product codes under this applicant name are LHI (Set, I.V. Fluid Transfer, 4); KPE (Container, I.V., 2); FPB (Filter, Infusion Line, 1).
Next steps
- See all 9 Healthtek, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LHI, Healthtek, 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.