Bio-Tek Instruments, Inc.: FDA filings under this applicant name
FDA lists 37 510(k) clearances under the applicant name “Bio-Tek Instruments, Inc.” (first 1980, latest 1997), across 19 product codes in 7 review panels. Median 510(k) review time under this name: 63 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 |
|---|---|---|---|
| JJQ | Colorimeter, Photometer, Spectrophotometer For Clinical Use | 14 | 14 |
| JTC | Device, Microtiter Diluting/Dispensing | 3 | 3 |
| DQA | Oximeter | 2 | 2 |
| DRL | Tester, Defibrillator | 2 | 2 |
| FRN | Pump, Infusion | 2 | 2 |
| CBK | Ventilator, Continuous, Facility Use | 1 | 1 |
| CCL | Analyzer, Gas, Oxygen, Gaseous-Phase | 1 | 1 |
| DPS | Electrocardiograph | 1 | 1 |
| DPZ | Oximeter, Ear | 1 | 1 |
| DRS | Transducer, Blood-Pressure, Extravascular | 1 | 1 |
Plus 9 more product codes.
Review panels
- Clinical Chemistry (15)
- Cardiovascular (7)
- Anesthesiology (5)
- Microbiology (3)
- General Hospital (2)
- Physical Medicine (2)
- General and Plastic Surgery (2)
Most recent Bio-Tek Instruments, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K973609 | IDA-4 AND IPT-MC | FRN | 1997-12-18 | 87 |
| K971273 | INDEX 2E, INDEX 2F, INDEX 2EF, CARDIOSAT 100E, CARDIOSAT 100F, CARDIOSAT 100EF | DQA | 1997-10-08 | 184 |
| K961862 | MODELS IDA-2 PLUS AND IPT-1 | FRN | 1997-02-26 | 288 |
| K954391 | MODELS QED-6, 6M AND 6H DEFIBRILLATOR ANALYZER WITH OPTIONAL UNIVERSAL PACEMAKER LOAD ADAPTER | DRL | 1995-11-17 | 59 |
| K953710 | ELX808 AUTOMATED MICROPLATE READERS | JJQ | 1995-10-25 | 77 |
| K953572 | ELX800UV | JJQ | 1995-10-19 | 80 |
| K950104 | ELX800 AND EL800 AUTOMATED MICROPLATE READERS | JJQ | 1995-03-21 | 69 |
| K942923 | CERES 900C & CERES UV900C | JJQ | 1995-02-06 | 230 |
| K944257 | LIONHEART 3 MULTI-PARAMETER SIMULATOR | DRT | 1994-09-21 | 21 |
| K933519 | INDEX SPO2 SIMULATOR | DQA | 1994-09-01 | 408 |
27 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Bio-Tek Instruments, 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 Bio-Tek Instruments, 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 Bio-Tek Instruments, Inc.?
FDA lists 37 510(k) clearances under the applicant name “Bio-Tek Instruments, Inc.” (first 1980, latest 1997), across 19 product codes in 7 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 Bio-Tek Instruments, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Bio-Tek Instruments, Inc. is 63 days.
Which FDA product codes appear under Bio-Tek Instruments, Inc.?
The most frequent FDA product codes under this applicant name are JJQ (Colorimeter, Photometer, Spectrophotometer For Clinical Use, 14); JTC (Device, Microtiter Diluting/Dispensing, 3); DQA (Oximeter, 2).
Next steps
- See all 37 Bio-Tek Instruments, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JJQ, Bio-Tek Instruments, 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.