MEDIVATORS ADVANTAGE NXT Automated Endoscope Reprocessor (K261791): 510(k) cleared for Steris
MEDIVATORS ADVANTAGE NXT Automated Endoscope Reprocessor (K261791): 510(k) cleared for Steris (Ohio): 510(k) cleared for Steris. Its amount of 126 is below the median of 138 (47th percentile). Dated 33 days ago, it serves as a historical benchmark. Score 36/100. As of 2026-11-03, from U.S. FDA openFDA (510(k) clearances and device enforcement reports).
Data as of · Compiled by Zalwin from U.S. FDA openFDA (510(k) clearances and device enforcement reports)
amount: 126 · 47th percentile of 414 FDAPulse records · 0.9x the median
Free preview: all 14 published fields of this record are shown below. Locked: 24 related OH FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K261791 |
| Device | MEDIVATORS ADVANTAGE NXT Automated Endoscope Reprocessor |
| Applicant | Steris |
| Specialty / panel | Gastroenterology, Urology |
| Product code | FEB |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-05-29 |
| Decision date | 2026-10-02 |
| Review time (days) | 126 |
| Third-party review | No |
| Applicant location | Mentor, OH, US |
| amount percentile | 47th of 414 (median 138, 0.9x median) |
| Peer records CSV (25 OH records) | 🔒 Click to unlock → |
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CSV columns: Record · Specialty · Date · Review days · Recall class · official source URL
- Source agency: U.S. FDA openFDA (510(k) clearances and device enforcement reports)
- Record date: 2026-10-02
- Data refreshed: 2026-11-03
- Refunds on request within 14 days
Top FDAPulse records (OH first): Vein360 Reprocessed LithoVue Digital Flexible Ureteroscope ( · Intra-Operative Positioning System (IOPS) and IOPS Visionary · ACHM30 AtriClip FLEX-Mini LAA Exclusion System (K263319) · Class II recall Z-0145-2027 · Class II recall Z-0154-2027 · Browse all by state and category →
LIVE PUBLIC DATA Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) · Last refreshed: Tue, 03 Nov 2026 18:05:14 GMT
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Peer benchmark and outreach value: MEDIVATORS ADVANTAGE NXT Automated Endoscope Reprocessor (K261791): 510(k) cleared for Steris and 25 Ohio peers
- Ohio FDAPulse records like this one: 25
- MEDIVATORS ADVANTAGE NXT Automated Endoscope Reprocessor (K261791): 510(k) cleared for Steris's amount: 47th percentile of 414 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every Ohio peer: $5,000 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
36 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- Fast 126-day review: this device is a strong predicate for similar products.
- Posted 33 days ago.
What is the FDAPulse record for MEDIVATORS ADVANTAGE NXT Automated Endoscope Reprocessor (K261791): 510(k) cleared for Steris in Ohio?
MEDIVATORS ADVANTAGE NXT Automated Endoscope Reprocessor (K261791) by Steris was cleared on 2026-10-02 after 126 days of review.
How does MEDIVATORS ADVANTAGE NXT Automated Endoscope Reprocessor (K261791): 510(k) cleared for Steris compare to other Ohio FDAPulse records?
Its amount of 126 is below the median (47th percentile); smaller records often move faster and face less competition. It is 33 days old, still within a typical 45-day follow-up window. Its Predicate Speed & CAPA Advisory Opportunity Score of 36/100 is modest; treat it as background rather than a priority.
MEDIVATORS ADVANTAGE NXT Automated Endoscope Reprocessor (K261791) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| MEDIVATORS ADVANTAGE NXT Automated Endoscope Reprocessor (K261791) | OH | 2026-10-02 |
| CapsoView (CVV); CapsoCloud (CLD) (K254230) | CA | 2026-09-25 |
| Drainage Catheter (K254179) | CN | 2026-09-18 |
| colonic FTRD Set (200.70); diagnostic FTRD Set (200.76); gastroduodenal FTRD Set (200.72) (K253481) | DE | 2026-09-14 |
Related records
- CapsoView (CVV); CapsoCloud (CLD) (K254230): 510(k) cleared for CapsoVision, Inc.
- Drainage Catheter (K254179): 510(k) cleared for Canyon Medical, Inc.
- colonic FTRD Set (200.70); diagnostic FTRD Set (200.76); gastroduodenal FTRD Set (200.72) (K253481): 510(k) cleared for Ovesco Endoscopy AG
- Polymed TUR Irrigation Set, Single Spike, Tubing 90 with Luer Lock - Sterile (30031 ); Polymed TUR Irrigation Set, Y-Type, 2 Leads, Tubing 90 with Luer Lock - Sterile (30032); Polymed TUR Irrigation Set, Y-Type, 4 Leads, Tubing, 90 with Luer Lock- Sterile (30033); Polymed TUR Irrigation Set, Sin
- Vein360 Reprocessed LithoVue Digital Flexible Ureteroscope (Standard Deflection); Vein360 Reprocessed LithoVue Digital Flexible Ureteroscope (Reverse Deflection) (K260708): 510(k) cleared for Vein 360
- multiFiltratePRO System (K261203): 510(k) cleared for Fresenius Medical Care Renal Therapies Group, LLC
- OpenFlo Urinary Catheter (K261141): 510(k) cleared for Urolution Medical, Inc.
- stentFIX System Set (100.50n) (K260487): 510(k) cleared for Ovesco Endoscopy AG
- Disposable Ureteral Access Sheath (K260512): 510(k) cleared for Yangzhou Fartley Medical Instrument Technology Co., Ltd.
- CADDIE (K260133): 510(k) cleared for Odin Medical Limited
- Single Use Ureteral Access Sheath (K260410): 510(k) cleared for Zhejiang Chuangxiang Medical Technology Co., Ltd.
- Rapid Barostat Bag (RBB) Pump and Catheter System (K262621): 510(k) cleared for Mui Scientific, Inc.
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