Gravity Blood Sets with 200µm Filter (K260261): 510(k) cleared for B.Braun Medical, Inc.
Gravity Blood Sets with 200µm Filter (K260261): 510(k) cleared for B.Braun Medical, Inc. (Pennsylvania): 510(k) cleared for B.Braun Medical, Inc. Its amount of 267 is above the median of 138 (88th percentile). Dated 13 days ago, it is in the active follow-up window. Score 67/100. 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: 267 · 88th percentile of 414 FDAPulse records · 1.9x the median
Free preview: all 14 published fields of this record are shown below. Locked: 18 related PA FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K260261 |
| Device | Gravity Blood Sets with 200µm Filter |
| Applicant | B.Braun Medical, Inc. |
| Specialty / panel | General Hospital |
| Product code | FPA |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-01-28 |
| Decision date | 2026-10-22 |
| Review time (days) | 267 |
| Third-party review | No |
| Applicant location | Bethlehem, PA, US |
| amount percentile | 88th of 414 (median 138, 1.9x median) |
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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: 2026-10-22
- Data refreshed: 2026-11-03
- Refunds on request within 14 days
Top FDAPulse records (PA first): 25G Huber Needle (K254095) · Pro-Line XL Power Injectable Central Venous Catheter and Pro · VacHeal Negative Pressure Wound Therapy System (K254160) · Ventricular Catheters, Thomale Catheter (K260044) · BoneVue (K254072) · 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: Gravity Blood Sets with 200µm Filter (K260261): 510(k) cleared for B.Braun Medical, Inc. and 19 Pennsylvania peers
- Pennsylvania FDAPulse records like this one: 19
- Gravity Blood Sets with 200µm Filter (K260261): 510(k) cleared for B.Braun Medical, Inc.'s amount: 88th percentile of 414 records
- Timing: Medium: dated in the last 30 days
- Estimated pipeline if you contact every Pennsylvania peer: $3,800 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
67 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- A long 267-day review suggests additional-information requests: a firm likely to value regulatory help next time.
- Posted 13 days ago.
What is the FDAPulse record for Gravity Blood Sets with 200µm Filter (K260261): 510(k) cleared for B.Braun Medical, Inc. in Pennsylvania?
Gravity Blood Sets with 200µm Filter (K260261) by B.Braun Medical, Inc. was cleared on 2026-10-22 after 267 days of review.
How does Gravity Blood Sets with 200µm Filter (K260261): 510(k) cleared for B.Braun Medical, Inc. compare to other Pennsylvania FDAPulse records?
Its amount of 267 sits in the upper half (88th percentile) of 414 records; the median is 138. It is fresh: dated 13 days ago, inside the window where early outreach matters most.
Gravity Blood Sets with 200µm Filter (K260261) vs. top 2 peers
| Organization | Location | Record date |
|---|---|---|
| Gravity Blood Sets with 200µm Filter (K260261) | PA | 2026-10-22 |
| Pro-Line XL Power Injectable Central Venous Catheter and Pro-Line XL Tunneler (K260080) | PA | 2026-10-09 |
| 25G Huber Needle (K254095) | PA | 2026-09-18 |
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