multiFiltratePRO System (K261203): 510(k) cleared for Fresenius Medical Care Renal Therapies Group, LLC
multiFiltratePRO System (K261203): 510(k) cleared for Fresenius Medical Care Renal Therapies Group, LLC (Massachusetts): 510(k) cleared for Fresenius Medical Care Renal Therapies Group, LLC. Its amount of 189 is above the median of 138 (67th percentile). Dated 16 days ago, it is in the active follow-up window. Score 48/100. 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: 189 · 67th percentile of 414 FDAPulse records · 1.4x the median
Free preview: all 14 published fields of this record are shown below. Locked: 40 related MA FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K261203 |
| Device | multiFiltratePRO System |
| Applicant | Fresenius Medical Care Renal Therapies Group, LLC |
| Specialty / panel | Gastroenterology, Urology |
| Product code | KDI |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-04-13 |
| Decision date | 2026-10-19 |
| Review time (days) | 189 |
| Third-party review | No |
| Applicant location | Waltham, MA, US |
| amount percentile | 67th of 414 (median 138, 1.4x median) |
| Peer records CSV (41 MA 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: 2026-10-19
- Data refreshed: 2026-11-03
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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: multiFiltratePRO System (K261203): 510(k) cleared for Fresenius Medical Care Renal Therapies Group, LLC and 41 Massachusetts peers
- Massachusetts FDAPulse records like this one: 41
- multiFiltratePRO System (K261203): 510(k) cleared for Fresenius Medical Care Renal Therapies Group, LLC's amount: 67th percentile of 414 records
- Timing: Medium: dated in the last 30 days
- Estimated pipeline if you contact every Massachusetts peer: $8,200 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
48 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- 189-day review, longer than typical.
- Posted 16 days ago.
What is the FDAPulse record for multiFiltratePRO System (K261203): 510(k) cleared for Fresenius Medical Care Renal Therapies Group, LLC in Massachusetts?
multiFiltratePRO System (K261203) by Fresenius Medical Care Renal Therapies Group, LLC was cleared on 2026-10-19 after 189 days of review.
How does multiFiltratePRO System (K261203): 510(k) cleared for Fresenius Medical Care Renal Therapies Group, LLC compare to other Massachusetts FDAPulse records?
Its amount of 189 sits in the upper half (67th percentile) of 414 records; the median is 138. It is 16 days old, still within a typical 45-day follow-up window.
multiFiltratePRO System (K261203) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| multiFiltratePRO System (K261203) | MA | 2026-10-19 |
| 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 |
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