Nk Biotechnical Engineering Co.: FDA filings under this applicant name
FDA lists 15 510(k) clearances under the applicant name “Nk Biotechnical Engineering Co.” (first 1991, latest 1994), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 90 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 |
|---|---|---|---|
| LBB | Dynamometer, Ac-Powered | 10 | 10 |
| KQX | Goniometer, Ac-Powered | 3 | 3 |
| KTZ | Caliper | 1 | 1 |
| LLN | Device, Vibration Threshold Measurement | 1 | 1 |
Review panels
- Neurology (14)
- Orthopedic (1)
Most recent Nk Biotechnical Engineering Co. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K934368 | NK PRESSURE-SPECIFIED SENSORY DEVICE, MODEL PSSD-001 | LLN | 1994-08-11 | 338 |
| K923965 | NK GRASP SENSOR, MODEL GA002 | LBB | 1993-05-12 | 278 |
| K923964 | NK GRASP SENSOR, MODEL GA001 | LBB | 1993-05-12 | 278 |
| K923963 | NK DIGI-GRIP SENSOR, MODEL DGR001 | LBB | 1993-03-31 | 236 |
| K921268 | NK DYNA-GRIP SENSOR, MODEL DG001 | LBB | 1992-07-14 | 120 |
| K921266 | NK MEDICAL MICROMETER, MODEL MC001 | KTZ | 1992-07-14 | 120 |
| K914062 | NK DEXTERITLY BOARD, MODEL BX001 | KQX | 1991-12-09 | 90 |
| K914061 | NK RANGE OF MOTION SENSOR, MODEL RM002 | KQX | 1991-12-09 | 90 |
| K914060 | RANGE OF MOTION SENSOR, MODEL RM001 | KQX | 1991-12-09 | 90 |
| K914059 | NK DEVIATION SENSOR, MODEL DV001 | LBB | 1991-12-09 | 90 |
5 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Nk Biotechnical Engineering Co..
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 Nk Biotechnical Engineering Co.?
FDA lists 15 510(k) clearances under the applicant name “Nk Biotechnical Engineering Co.” (first 1991, latest 1994), across 4 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 Nk Biotechnical Engineering Co.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Nk Biotechnical Engineering Co. is 90 days.
Which FDA product codes appear under Nk Biotechnical Engineering Co.?
The most frequent FDA product codes under this applicant name are LBB (Dynamometer, Ac-Powered, 10); KQX (Goniometer, Ac-Powered, 3); KTZ (Caliper, 1).
Next steps
- See all 15 Nk Biotechnical Engineering Co. clearances with predicates and recalls
- Run predicate analysis for product code LBB, Nk Biotechnical Engineering Co.'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.