OOOPDS (K254214): 510(k) cleared for Taiwan Main Orthopaedic Biotechnology Co., Ltd.
OOOPDS (K254214): 510(k) cleared for Taiwan Main Orthopaedic Biotechnology Co., Ltd.: 510(k) cleared for Taiwan Main Orthopaedic Biotechnology Co., Ltd. Its amount of 260 is above the median of 138 (82nd percentile). Dated 50 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: 260 · 82th percentile of 414 FDAPulse records · 1.9x the median
Free preview: all 14 published fields of this record are shown below. Locked: 3 related TW FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K254214 |
| Device | OOOPDS |
| Applicant | Taiwan Main Orthopaedic Biotechnology Co., Ltd. |
| Specialty / panel | Radiology |
| Product code | LLZ |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2025-12-29 |
| Decision date | 2026-09-15 |
| Review time (days) | 260 |
| Third-party review | No |
| Applicant location | Taichung, TW |
| amount percentile | 82th of 414 (median 138, 1.9x median) |
| Peer records CSV (4 TW 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: 2026-09-15
- Data refreshed: 2026-11-03
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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: OOOPDS (K254214): 510(k) cleared for Taiwan Main Orthopaedic Biotechnology Co., Ltd. and 4 TW peers
- TW FDAPulse records like this one: 4
- OOOPDS (K254214): 510(k) cleared for Taiwan Main Orthopaedic Biotechnology Co., Ltd.'s amount: 82nd percentile of 414 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every TW peer: $800 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
55 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- A long 260-day review suggests additional-information requests: a firm likely to value regulatory help next time.
What is the FDAPulse record for OOOPDS (K254214): 510(k) cleared for Taiwan Main Orthopaedic Biotechnology Co., Ltd.?
OOOPDS (K254214) by Taiwan Main Orthopaedic Biotechnology Co., Ltd. was cleared on 2026-09-15 after 260 days of review.
How does OOOPDS (K254214): 510(k) cleared for Taiwan Main Orthopaedic Biotechnology Co., Ltd. compare to other FDAPulse records?
Its amount of 260 sits in the upper half (82th percentile) of 414 records; the median is 138. It is 50 days old; check the official source for later updates before acting.
OOOPDS (K254214) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| OOOPDS (K254214) | TW | 2026-09-15 |
| VenusCT (K260510) | CA | 2026-10-19 |
| AVIEW Aorta Metrics (K260391) | KR | 2026-10-16 |
| Vista AI Scan (K260092) | CA | 2026-10-07 |
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