Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Medipurpose Pte. , Ltd. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
152 daysmedian FDA review time
234 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K222224 | SurgiLanceĀ® Safety Lancet | Medipurpose Pte. , Ltd. | 2022-09-22 | 59 | 0 |
| K130132 | BABYLANCE HEEL INCISION DEVICE | Medipurpose Pte. , Ltd. | 2013-02-11 | 24 | 0 |
| K110062 | MEDIPLUS-FOAM AG; MEDIPLUS-COMFORTFOAM AG; MEDIPLUS-SUPERFOA | Medipurpose Pte. , Ltd. | 2011-09-01 | 234 | 0 |
| K101145 | SURGILANCE SAFETY LANCETS, MODELS SLN100, SLN200, SLN240, SL | Medipurpose Pte. , Ltd. | 2010-10-21 | 181 | 0 |
| K101417 | BABYLANCE HEEL INCISION DEVICE , MODELS BLP50, BLP200, BLN50 | Medipurpose Pte. , Ltd. | 2010-10-19 | 152 | 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