Rapid Barostat Bag (RBB) Pump and Catheter System (K262621): 510(k) cleared for Mui Scientific, Inc.
Rapid Barostat Bag (RBB) Pump and Catheter System (K262621): 510(k) cleared for Mui Scientific, Inc. (California): 510(k) cleared for Mui Scientific, Inc. Its amount of 64 is below the median of 138 (19th percentile). Dated 35 days ago, it serves as a historical benchmark. Score 41/100. 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: 64 · 19th percentile of 414 FDAPulse records · 0.5x the median
Free preview: all 14 published fields of this record are shown below. Locked: 75 related CA FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K262621 |
| Device | Rapid Barostat Bag (RBB) Pump and Catheter System |
| Applicant | Mui Scientific, Inc. |
| Specialty / panel | Gastroenterology, Urology |
| Product code | FFX |
| Device class | 2 |
| Clearance type | Special |
| Decision | Substantially Equivalent |
| Received | 2026-07-28 |
| Decision date | 2026-09-30 |
| Review time (days) | 64 |
| Third-party review | No |
| Applicant location | Mississauga, CA |
| amount percentile | 19th of 414 (median 138, 0.5x median) |
| Peer records CSV (76 CA 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: 2026-09-30
- Data refreshed: 2026-11-03
- Refunds on request within 14 days
Top FDAPulse records (CA first): Triever Duo Catheter (K253419) · Helo Return (K253717) · DistaSense(TM) (v1) (K254058) · BD OneFlow LST; BD OneFlow B-CLPD T1; BD FACSLyric Flow Cyto · CapsoView (CVV); CapsoCloud (CLD) (K254230) · 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: Rapid Barostat Bag (RBB) Pump and Catheter System (K262621): 510(k) cleared for Mui Scientific, Inc. and 76 California peers
- California FDAPulse records like this one: 76
- Rapid Barostat Bag (RBB) Pump and Catheter System (K262621): 510(k) cleared for Mui Scientific, Inc.'s amount: 19th percentile of 414 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every California peer: $15,200 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
41 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- Fast 64-day review: this device is a strong predicate for similar products.
- Special 510(k): a modification of an existing device.
- Posted 35 days ago.
What is the FDAPulse record for Rapid Barostat Bag (RBB) Pump and Catheter System (K262621): 510(k) cleared for Mui Scientific, Inc. in California?
Rapid Barostat Bag (RBB) Pump and Catheter System (K262621) by Mui Scientific, Inc. was cleared on 2026-09-30 after 64 days of review.
How does Rapid Barostat Bag (RBB) Pump and Catheter System (K262621): 510(k) cleared for Mui Scientific, Inc. compare to other California FDAPulse records?
Its amount of 64 is below the median (19th percentile); smaller records often move faster and face less competition. It is 35 days old, still within a typical 45-day follow-up window.
Rapid Barostat Bag (RBB) Pump and Catheter System (K262621) vs. top 2 peers
| Organization | Location | Record date |
|---|---|---|
| Rapid Barostat Bag (RBB) Pump and Catheter System (K262621) | CA | 2026-09-30 |
| CapsoView (CVV); CapsoCloud (CLD) (K254230) | CA | 2026-09-25 |
| da Vinci 5 Handheld Camera Head (470080);da Vinci 5 Handheld Camera Laparoscope, 0 degree (470081);da Vinci 5 Handheld Camera Laparoscope, 30 degree (470082);da Vinci 5 Handheld Camera Tray (400526);da Vinci 5 Firefly Imaging System (K262455) | CA | 2026-10-14 |
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