Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Sheathing Technologies, Inc. · Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
101 daysmedian FDA review time
268 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K153212 | Sheathes Ultrasound Probe Covers | Sheathing Technologies, Inc. | 2016-03-04 | 120 | 1 |
| K130041 | SHEATHES STERILE ULTRASOUND GEL | Sheathing Technologies, Inc. | 2013-02-06 | 29 | 0 |
| K112827 | SHEATHES ULTRASOND GEL | Sheathing Technologies, Inc. | 2012-06-22 | 268 | 0 |
| K100966 | COLONOSCOPE/SIGMOIDOSCOPE SHEATHES | Sheathing Technologies, Inc. | 2010-08-03 | 117 | 0 |
| K091828 | SHEATHESISO ULTRASOUND TRANSDUCER COVER | Sheathing Technologies, Inc. | 2009-09-28 | 101 | 0 |
| K043425 | SHEATHES NEEDLE GUIDE, MODEL NG-SR-A-484-KIT (THERE WILL BE | Sheathing Technologies, Inc. | 2005-02-28 | 77 | 0 |
| K990175 | SHEATHES (NON-LATEX), STERILE | Sheathing Technologies, Inc. | 1999-04-21 | 92 | 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