Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Te ME NA S.A.R.L. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
576 daysmedian FDA review time
969 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K990323 | TE ME NA POLYSTIM NERVE STIMILATOR | Te ME NA S.A.R.L. | 2001-09-28 | 969 | 1 |
| K002405 | SPINAL EPIDURAL NEEDLES | Te ME NA S.A.R.L. | 2001-06-01 | 298 | 0 |
| K991259 | TE ME NA EPIDURAL CATHETER | Te ME NA S.A.R.L. | 2001-02-21 | 680 | 0 |
| K990100 | POLYMEDIC UPA NERVE STIMULATION NEEDLE; POLYMEDIC UPC NERVE | Te ME NA S.A.R.L. | 2000-08-02 | 576 | 19 |
| K990020 | TE ME NA LOSS OF RESISTANCE SYRINGE, 10CC | Te ME NA S.A.R.L. | 1999-06-24 | 171 | 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