Medi Astro Total and Partial Ossicular Prostheses (Type TORP, Type PORP, and Type PISTON) (K260264): 510(k) cleared for Shanghai Medi Astro Technology Co., Ltd.
Medi Astro Total and Partial Ossicular Prostheses (Type TORP, Type PORP, and Type PISTON) (K260264): 510(k) cleared for Shanghai Medi Astro Technology Co., Ltd.: 510(k) cleared for Shanghai Medi Astro Technology Co., Ltd. Its amount of 259 is above the median of 138 (82nd percentile). Dated 21 days ago, it is in the active follow-up window. Score 61/100. 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: 259 · 82th 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 | K260264 |
| Device | Medi Astro Total and Partial Ossicular Prostheses (Type TORP, Type PORP, and Type PISTON) |
| Applicant | Shanghai Medi Astro Technology Co., Ltd. |
| Specialty / panel | Other |
| Product code | ETA |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-01-28 |
| Decision date | 2026-10-14 |
| Review time (days) | 259 |
| Third-party review | No |
| Applicant location | Shanghai, CN |
| amount percentile | 82th 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: 2026-10-14
- 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 09:16:12 GMT
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Peer benchmark and outreach value: Medi Astro Total and Partial Ossicular Prostheses (Type TORP, Type PORP, and Type PISTON) (K260264): 510(k) cleared for Shanghai Medi Astro Technology Co., Ltd. and 76 CN peers
- CN FDAPulse records like this one: 76
- Medi Astro Total and Partial Ossicular Prostheses (Type TORP, Type PORP, and Type PISTON) (K260264): 510(k) cleared for Shanghai Medi Astro Technology Co., Ltd.'s amount: 82nd 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)
61 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- A long 259-day review suggests additional-information requests: a firm likely to value regulatory help next time.
- Posted 21 days ago.
What is the FDAPulse record for Medi Astro Total and Partial Ossicular Prostheses (Type TORP, Type PORP, and Type PISTON) (K260264): 510(k) cleared for Shanghai Medi Astro Technology Co., Ltd.?
Medi Astro Total and Partial Ossicular Prostheses (Type TORP, Type PORP, and Type PISTON) (K260264) by Shanghai Medi Astro Technology Co., Ltd. was cleared on 2026-10-14 after 259 days of review.
How does Medi Astro Total and Partial Ossicular Prostheses (Type TORP, Type PORP, and Type PISTON) (K260264): 510(k) cleared for Shanghai Medi Astro Technology Co., Ltd. compare to other FDAPulse records?
Its amount of 259 sits in the upper half (82th percentile) of 414 records; the median is 138. It is 21 days old, still within a typical 45-day follow-up window.
Medi Astro Total and Partial Ossicular Prostheses (Type TORP, Type PORP, and Type PISTON) (K260264) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| Medi Astro Total and Partial Ossicular Prostheses (Type TORP, Type PORP, and Type PISTON) (K260264) | CN | 2026-10-14 |
| Needle Stimulator (SDZ-IIB, SDZ-IIC, SDZ-III, SDZ-V) (K260230) | CN | 2026-10-22 |
| STA® - Liquid Anti-Xa (K260214) | NJ | 2026-09-24 |
| BD OneFlow LST; BD OneFlow B-CLPD T1; BD FACSLyric Flow Cytometer, 8-color [4-2-2], 10-color [4-3-3], 12-color (4-3-5) (K260215) | CA | 2026-10-20 |
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