Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Nk Biotechnical Engineering Co. — Predicate Candidate Screening
15 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
90 daysmedian FDA review time
278 days90th percentile
15clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K934368 | NK PRESSURE-SPECIFIED SENSORY DEVICE, MODEL PSSD-001 | Nk Biotechnical Engineering Co. | 1994-08-11 | 338 | 0 |
| K923965 | NK GRASP SENSOR, MODEL GA002 | Nk Biotechnical Engineering Co. | 1993-05-12 | 278 | 0 |
| K923964 | NK GRASP SENSOR, MODEL GA001 | Nk Biotechnical Engineering Co. | 1993-05-12 | 278 | 0 |
| K923963 | NK DIGI-GRIP SENSOR, MODEL DGR001 | Nk Biotechnical Engineering Co. | 1993-03-31 | 236 | 0 |
| K921266 | NK MEDICAL MICROMETER, MODEL MC001 | Nk Biotechnical Engineering Co. | 1992-07-14 | 120 | 0 |
| K921268 | NK DYNA-GRIP SENSOR, MODEL DG001 | Nk Biotechnical Engineering Co. | 1992-07-14 | 120 | 0 |
| K914057 | NK PINCH SENSOR, MODEL PA001 | Nk Biotechnical Engineering Co. | 1991-12-09 | 90 | 0 |
| K914060 | RANGE OF MOTION SENSOR, MODEL RM001 | Nk Biotechnical Engineering Co. | 1991-12-09 | 90 | 0 |
| K914061 | NK RANGE OF MOTION SENSOR, MODEL RM002 | Nk Biotechnical Engineering Co. | 1991-12-09 | 90 | 0 |
| K914062 | NK DEXTERITLY BOARD, MODEL BX001 | Nk Biotechnical Engineering Co. | 1991-12-09 | 90 | 0 |
| K914055 | PINCH SENSOR, MODEL PF001 | Nk Biotechnical Engineering Co. | 1991-12-09 | 90 | 0 |
| K914054 | NK GRASP SENSOR, MODEL GR001 | Nk Biotechnical Engineering Co. | 1991-12-09 | 90 | 0 |
| K914059 | NK DEVIATION SENSOR, MODEL DV001 | Nk Biotechnical Engineering Co. | 1991-12-09 | 90 | 0 |
| K914056 | NK PINCH SENSOR, MODEL PF002 | Nk Biotechnical Engineering Co. | 1991-12-09 | 90 | 0 |
| K914058 | NK PINCH SENSOR, MODEL PA002 | Nk Biotechnical Engineering Co. | 1991-12-06 | 87 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda