Facial Therapy Mask (Z1, Z2,Z3, Z5,Z6, Z7,Z8,Z9) (K262752): 510(k) cleared for Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd.
Facial Therapy Mask (Z1, Z2,Z3, Z5,Z6, Z7,Z8,Z9) (K262752): 510(k) cleared for Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd.: 510(k) cleared for Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd. Its amount of 81 is below the median of 138 (23rd percentile). Dated 13 days ago, it is in the active follow-up window. Score 42/100. 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: 81 · 23th percentile of 414 FDAPulse records · 0.6x 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 | K262752 |
| Device | Facial Therapy Mask (Z1, Z2,Z3, Z5,Z6, Z7,Z8,Z9) |
| Applicant | Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd. |
| Specialty / panel | General, Plastic Surgery |
| Product code | OHS |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-08-03 |
| Decision date | 2026-10-23 |
| Review time (days) | 81 |
| Third-party review | No |
| Applicant location | Shenzhen, CN |
| amount percentile | 23th of 414 (median 138, 0.6x median) |
| Peer records CSV (76 CN 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: 2026-10-23
- Data refreshed: 2026-11-04
- Refunds on request within 14 days
Top FDAPulse records (CN first): TECAR Therapy Device (TC2000, TC2001) (K252288) · BreathCare PAP III (YH-390N) (K260251) · Needle Stimulator (SDZ-IIB, SDZ-IIC, SDZ-III, SDZ-V) (K26023 · Mesh Nebulizer (UN204); Mesh Nebulizer (UN205); Mesh Nebuliz · Drainage Catheter (K254179) · Browse all by state and category →
LIVE PUBLIC DATA Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) · Last refreshed: Wed, 04 Nov 2026 21:30:53 GMT
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Peer benchmark and outreach value: Facial Therapy Mask (Z1, Z2,Z3, Z5,Z6, Z7,Z8,Z9) (K262752): 510(k) cleared for Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd. and 76 CN peers
- CN FDAPulse records like this one: 76
- Facial Therapy Mask (Z1, Z2,Z3, Z5,Z6, Z7,Z8,Z9) (K262752): 510(k) cleared for Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd.'s amount: 23rd percentile of 414 records
- Timing: Medium: dated in the last 30 days
- Estimated pipeline if you contact every CN peer: $15,200 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
42 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- Fast 81-day review: this device is a strong predicate for similar products.
- Posted 13 days ago.
What is the FDAPulse record for Facial Therapy Mask (Z1, Z2,Z3, Z5,Z6, Z7,Z8,Z9) (K262752): 510(k) cleared for Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd.?
Facial Therapy Mask (Z1, Z2,Z3, Z5,Z6, Z7,Z8,Z9) (K262752) by Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd. was cleared on 2026-10-23 after 81 days of review.
How does Facial Therapy Mask (Z1, Z2,Z3, Z5,Z6, Z7,Z8,Z9) (K262752): 510(k) cleared for Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd. compare to other FDAPulse records?
Its amount of 81 is below the median (23th percentile); smaller records often move faster and face less competition. It is fresh: dated 13 days ago, inside the window where early outreach matters most.
Facial Therapy Mask (Z1, Z2,Z3, Z5,Z6, Z7,Z8,Z9) (K262752) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| Facial Therapy Mask (Z1, Z2,Z3, Z5,Z6, Z7,Z8,Z9) (K262752) | CN | 2026-10-23 |
| 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 |
| Nd | CN | 2026-10-13 |
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Recent FDA 510(k) clearances FDA 510(k) clearances and recalls: General & Plastic Surgery devices
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