25G Huber Needle (K254095): 510(k) cleared for Martech Medical Products
25G Huber Needle (K254095): 510(k) cleared for Martech Medical Products (Pennsylvania): 510(k) cleared for Martech Medical Products. Its amount of 273 is top-decile (95th percentile of 414 records). Dated 47 days ago, it serves as a historical benchmark. Score 55/100. 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: 273 · 95th percentile of 414 FDAPulse records · 2.0x 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 | K254095 |
| Device | 25G Huber Needle |
| Applicant | Martech Medical Products |
| Specialty / panel | General Hospital |
| Product code | PTI |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2025-12-19 |
| Decision date | 2026-09-18 |
| Review time (days) | 273 |
| Third-party review | No |
| Applicant location | Harleysville, PA, US |
| amount percentile | 95th of 414 (median 138, 2.0x median) |
| Peer records CSV (19 PA records) | 🔒 Click to unlock → |
| CRM-ready export with official source URLs | 🔒 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: 2026-09-18
- Data refreshed: 2026-11-03
- Refunds on request within 14 days
Top FDAPulse records (PA first): Pro-Line XL Power Injectable Central Venous Catheter and Pro · VacHeal Negative Pressure Wound Therapy System (K254160) · Ventricular Catheters, Thomale Catheter (K260044) · Gravity Blood Sets with 200µm Filter (K260261) · 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: 25G Huber Needle (K254095): 510(k) cleared for Martech Medical Products and 19 Pennsylvania peers
- Pennsylvania FDAPulse records like this one: 19
- 25G Huber Needle (K254095): 510(k) cleared for Martech Medical Products's amount: 95th percentile of 414 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every Pennsylvania peer: $3,800 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
55 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- A long 273-day review suggests additional-information requests: a firm likely to value regulatory help next time.
What is the FDAPulse record for 25G Huber Needle (K254095): 510(k) cleared for Martech Medical Products in Pennsylvania?
25G Huber Needle (K254095) by Martech Medical Products was cleared on 2026-09-18 after 273 days of review.
How does 25G Huber Needle (K254095): 510(k) cleared for Martech Medical Products compare to other Pennsylvania FDAPulse records?
This is a top-decile record: its amount of 273 is 2.0x the median of 138 across 414 records. It is 47 days old; check the official source for later updates before acting.
25G Huber Needle (K254095) vs. top 2 peers
| Organization | Location | Record date | Compare |
|---|---|---|---|
| 25G Huber Needle (K254095) | PA | 2026-09-18 | This record |
| Gravity Blood Sets with 200µm Filter (K260261) | PA | 2026-10-22 | View record → |
| Pro-Line XL Power Injectable Central Venous Catheter and Pro-Line XL Tunneler (K260080) | PA | 2026-10-09 | Compare 25G Huber Needle (K254095) vs Pro-Line XL Power Injectable Central Venous Catheter and Pro-Line XL Tunneler (K260080) → |
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