Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Encompass Group, LLC — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K203085 | NOVA Patient Warming System | Encompass Group, LLC | 2020-11-12 | 30 | 0 |
| K982058 | ROTECNO FR (FLUID RESISTANT) SURGICAL GOWN | Encompass Group, LLC | 1999-01-14 | 217 | 0 |
| K982059 | ROTECNO 2000 SURGICAL GOWN | Encompass Group, LLC | 1998-11-30 | 172 | 0 |
| K760618 | PATIENT RESTRAINT | Encompass Group, LLC | 1976-11-24 | 72 | 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