Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Exact Medical Manufacturing, Inc. · Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
96 daysmedian FDA review time
227 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K121919 | SURGICAL DRAPE WITH AAMI LIQUID BARRIER LEVEL IV | Exact Medical Manufacturing, Inc. | 2013-02-14 | 227 | 0 |
| K120045 | EMM HIGH PERFORMANCE SURGICAL GOWN WITH AAMI LIQUID BARRIER | Exact Medical Manufacturing, Inc. | 2012-06-12 | 158 | 0 |
| K111535 | EMM SURGICAL GOWN - SPUNLACE WITH PE LAYER | Exact Medical Manufacturing, Inc. | 2011-08-26 | 85 | 0 |
| K101598 | EMM SURGICAL DRAPE SMS W/PE SIDES MODEL 13-005 (WITH MINOR D | Exact Medical Manufacturing, Inc. | 2010-10-04 | 118 | 0 |
| K101688 | EMM SURGICAL DRAPE-SPUNLACE W/PE SIDES, MODEL 13-004 | Exact Medical Manufacturing, Inc. | 2010-09-20 | 96 | 0 |
| K101689 | EMM EQUIPMENT COVER-POLYTHYLENE | Exact Medical Manufacturing, Inc. | 2010-09-20 | 96 | 0 |
| K101593 | EMM SURGICAL GOWN-SMS WITH PE LAYER, MODEL 18-501 L, 18-501- | Exact Medical Manufacturing, Inc. | 2010-09-03 | 87 | 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