Bio-Detek, Inc.: FDA filings under this applicant name
FDA lists 17 510(k) clearances under the applicant name “Bio-Detek, Inc.” (first 1985, latest 2015), across 6 product codes in 3 review panels. Median 510(k) review time under this name: 93 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 | 1 | 332 |
| 2015 | 2 | 102 |
| 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 |
|---|---|---|---|
| MKJ | Automated External Defibrillators (Non-Wearable) | 10 | 10 |
| DRX | Electrode, Electrocardiograph | 3 | 3 |
| GXY | Electrode, Cutaneous | 1 | 1 |
| GXZ | Electrode, Needle | 1 | 1 |
| HAM | Apparatus, Electrosurgical | 1 | 1 |
| LIX | Aid, Cardiopulmonary Resuscitation | 1 | 1 |
Review panels
- Cardiovascular (14)
- Neurology (2)
- General and Plastic Surgery (1)
Most recent Bio-Detek, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K150198 | CPR Dura-Padz Reusable Defibrillation Electrode with Dura-padz Gel | MKJ | 2015-05-02 | 93 |
| K150055 | OneStep Pediatric CPR Multi-Function Electrode | MKJ | 2015-05-02 | 110 |
| K133441 | ONESTEP CPR II MULTI-FUNCTION ELECTRODE | MKJ | 2014-10-10 | 332 |
| K100565 | DURA PADZ (REUSABLE ELECTRODE), DURA PADZ GEL (DISPOSABLE HYDROGEL) MODEL 8900-0300, 8900-0325 | MKJ | 2010-11-16 | 260 |
| K071321 | POCKETCPR | LIX | 2007-09-12 | 125 |
| K040256 | PEDI-PADZ RADIOLUCENT MULTI-FUNCTION PEDIATRIC ELECTRODES, MODEL 8900-1005 | MKJ | 2004-04-09 | 65 |
| K040056 | BIO-DETEK ELECTRODE ADAPTER, MODEL R2001-90 | MKJ | 2004-04-09 | 87 |
| K033771 | BIO-DETEK MODIFIED ADULT MULTI-FUNCTION ELECTRODE WITH CONNECTOR | MKJ | 2004-02-27 | 86 |
| K984582 | ZOLL SUPERPADZ ADULT MULTI-FUNCTION ELECTRODES, MODEL 8900-XXXX | MKJ | 1999-03-16 | 83 |
| K990106 | ZOLL FIRST RESPONDER PADZ ADULT DEFIBRILLATION ELECTRODES | MKJ | 1999-02-26 | 45 |
7 earlier clearances. See the full list in Caduvo.
Recalls
12 product recalls in 7 recall events; 0 initiated in the last five years. Most recent: 2019-05-28.
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 Bio-Detek, Inc.?
FDA lists 17 510(k) clearances under the applicant name “Bio-Detek, Inc.” (first 1985, latest 2015), across 6 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 Bio-Detek, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Bio-Detek, Inc. is 93 days.
Which FDA product codes appear under Bio-Detek, Inc.?
The most frequent FDA product codes under this applicant name are MKJ (Automated External Defibrillators (Non-Wearable), 10); DRX (Electrode, Electrocardiograph, 3); GXY (Electrode, Cutaneous, 1).
Next steps
- See all 17 Bio-Detek, Inc. clearances with predicates and recalls
- Run predicate analysis for product code MKJ, Bio-Detek, 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.