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VacHeal Negative Pressure Wound Therapy System (K254160): 510(k) cleared for VacHeal, LLC
VacHeal Negative Pressure Wound Therapy System (K254160): 510(k) cleared for VacHeal, LLC (Pennsylvania): 510(k) cleared for VacHeal, LLC. Its amount of 270 is top-decile (94th 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: 270 · 94th 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 | K254160 |
| Device | VacHeal Negative Pressure Wound Therapy System |
| Applicant | VacHeal, LLC |
| Specialty / panel | General, Plastic Surgery |
| Product code | OKO |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2025-12-22 |
| Decision date | 2026-09-18 |
| Review time (days) | 270 |
| Third-party review | No |
| Applicant location | Ardmore, PA, US |
| amount percentile | 94th 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
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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: VacHeal Negative Pressure Wound Therapy System (K254160): 510(k) cleared for VacHeal, LLC and 19 Pennsylvania peers
- Pennsylvania FDAPulse records like this one: 19
- VacHeal Negative Pressure Wound Therapy System (K254160): 510(k) cleared for VacHeal, LLC's amount: 94th 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 270-day review suggests additional-information requests: a firm likely to value regulatory help next time.
What is the FDAPulse record for VacHeal Negative Pressure Wound Therapy System (K254160): 510(k) cleared for VacHeal, LLC in Pennsylvania?
VacHeal Negative Pressure Wound Therapy System (K254160) by VacHeal, LLC was cleared on 2026-09-18 after 270 days of review.
How does VacHeal Negative Pressure Wound Therapy System (K254160): 510(k) cleared for VacHeal, LLC compare to other Pennsylvania FDAPulse records?
This is a top-decile record: its amount of 270 is 2.0x the median of 138 across 414 records. It is 47 days old; check the official source for later updates before acting.
VacHeal Negative Pressure Wound Therapy System (K254160) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| VacHeal Negative Pressure Wound Therapy System (K254160) | PA | 2026-09-18 |
| TECAR Therapy Device (TC2000, TC2001) (K252288) | CN | 2026-10-13 |
| easyEndo E-Lite Single Use Powered Endoscopic Staplers; easyEndo E-Lite Single Use Powered Endoscopic Staplers with Curved Tip; easyEndo E-Lite Single Use Cartridges (K254291) | CN | 2026-09-25 |
| PicoreMax (PicoreMax) (K254199) | KR | 2026-09-24 |
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