Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
NormaTec Industries, LP · Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
41 daysmedian FDA review time
96 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K251905 | Normatec Elite Hip | NormaTec Industries, LP | 2025-09-18 | 90 | 0 |
| K240122 | Normatec Elite | NormaTec Industries, LP | 2024-03-21 | 65 | 0 |
| K221666 | Normatec Go | NormaTec Industries, LP | 2022-07-14 | 36 | 0 |
| K220217 | Normatec 3 | NormaTec Industries, LP | 2022-02-25 | 30 | 0 |
| K183169 | Pulse 2.0, Pulse Pro 2.0 | NormaTec Industries, LP | 2018-12-27 | 41 | 0 |
| K183328 | Pulse Rx 2.0, Pulse Pro Rx 2.0 | NormaTec Industries, LP | 2018-12-21 | 21 | 0 |
| K161346 | NormaTec PCD-T and PCD-B | NormaTec Industries, LP | 2016-06-15 | 30 | 0 |
| K160608 | NormaTec Pulse and NormaTec Pulse Pro | NormaTec Industries, LP | 2016-04-13 | 41 | 0 |
| K112890 | NORMATEC MVP | NormaTec Industries, LP | 2012-01-04 | 96 | 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