Disposable Sterile Skull Drill (LZ) (K254177): 510(k) cleared for Guizhou Zirui Technology Co., Ltd.
Disposable Sterile Skull Drill (LZ) (K254177): 510(k) cleared for Guizhou Zirui Technology Co., Ltd.: 510(k) cleared for Guizhou Zirui Technology Co., Ltd. Its amount of 262 is above the median of 138 (84th percentile). Dated 55 days ago, it serves as a historical benchmark. Score 55/100. As of 2026-11-04, 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: 262 · 84th percentile of 414 FDAPulse records · 1.9x the median
Free preview: all 14 published fields of this record are shown below. Locked: 75 related CN FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K254177 |
| Device | Disposable Sterile Skull Drill (LZ) |
| Applicant | Guizhou Zirui Technology Co., Ltd. |
| Specialty / panel | Neurology |
| Product code | HBF |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2025-12-23 |
| Decision date | 2026-09-11 |
| Review time (days) | 262 |
| Third-party review | No |
| Applicant location | Zunyi, CN |
| amount percentile | 84th of 414 (median 138, 1.9x median) |
| Peer records CSV (76 CN 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: 2026-09-11
- Data refreshed: 2026-11-04
- 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: Wed, 04 Nov 2026 09:16:12 GMT
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Peer benchmark and outreach value: Disposable Sterile Skull Drill (LZ) (K254177): 510(k) cleared for Guizhou Zirui Technology Co., Ltd. and 76 CN peers
- CN FDAPulse records like this one: 76
- Disposable Sterile Skull Drill (LZ) (K254177): 510(k) cleared for Guizhou Zirui Technology Co., Ltd.'s amount: 84th percentile of 414 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every CN peer: $15,200 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
55 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- A long 262-day review suggests additional-information requests: a firm likely to value regulatory help next time.
What is the FDAPulse record for Disposable Sterile Skull Drill (LZ) (K254177): 510(k) cleared for Guizhou Zirui Technology Co., Ltd.?
Disposable Sterile Skull Drill (LZ) (K254177) by Guizhou Zirui Technology Co., Ltd. was cleared on 2026-09-11 after 262 days of review.
How does Disposable Sterile Skull Drill (LZ) (K254177): 510(k) cleared for Guizhou Zirui Technology Co., Ltd. compare to other FDAPulse records?
Its amount of 262 sits in the upper half (84th percentile) of 414 records; the median is 138. It is 55 days old; check the official source for later updates before acting.
Disposable Sterile Skull Drill (LZ) (K254177) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| Disposable Sterile Skull Drill (LZ) (K254177) | CN | 2026-09-11 |
| 7D Surgical System (10-0001) (K260403) | CA | 2026-10-19 |
| cCeLL - In vivo (K260315) | KR | 2026-10-16 |
| Neurora (K260064) | NH | 2026-10-02 |
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