Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Nsp Tech Pte, Ltd. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
169 daysmedian FDA review time
393 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K221783 | SafetiCET Safety Lancet | Nsp Tech Pte, Ltd. | 2022-10-24 | 125 | 0 |
| K221604 | SafetiHeel, MediHeel, Novaplus | Nsp Tech Pte, Ltd. | 2022-08-22 | 81 | 0 |
| K193074 | Bevel Up Holder | Nsp Tech Pte, Ltd. | 2020-04-21 | 169 | 0 |
| K181743 | Blood Transfer Accessory (BTA) | Nsp Tech Pte, Ltd. | 2019-07-30 | 393 | 0 |
| K181754 | Blood Collection Accessory (BUCA) | Nsp Tech Pte, Ltd. | 2019-07-30 | 393 | 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