FDAPulse / report
Venti-Trach Tracheostomy Tube (570 Series); Venti-Trach Tracheostomy Tube (571 Series); Venti-Trach Tracheostomy Tube (580 Series); Venti-Trach Tracheostomy Tube (581 Series) (K253063): 510(k) cleared for Vitaltec Corporation
Venti-Trach Tracheostomy Tube (570 Series); Venti-Trach Tracheostomy Tube (571 Series); Venti-Trach Tracheostomy Tube (580 Series); Venti-Trach Tracheostomy Tube (581 Series) (K253063): 510(k) cleared for Vitaltec Corporation: 510(k) cleared for Vitaltec Corporation. Its amount of 354 is top-decile (98th percentile of 414 records). Dated 54 days ago, it serves as a historical benchmark. Score 60/100. 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: 354 · 98th percentile of 414 FDAPulse records · 2.6x 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 | K253063 |
| Device | Venti-Trach Tracheostomy Tube (570 Series); Venti-Trach Tracheostomy Tube (571 Series); Venti-Trach Tracheostomy Tube (580 Series); Venti-Trach Tracheostomy Tube (581 Series) |
| Applicant | Vitaltec Corporation |
| Specialty / panel | Anesthesiology |
| Product code | BTO |
| Device class | 2 |
| Clearance type | Special |
| Decision | Substantially Equivalent |
| Received | 2025-09-22 |
| Decision date | 2026-09-11 |
| Review time (days) | 354 |
| Third-party review | No |
| Applicant location | Taichung City, TW |
| amount percentile | 98th of 414 (median 138, 2.6x median) |
| Peer records CSV (4 TW records) | 🔒 Click to unlock → |
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Watch Venti-Trach Tracheostomy Tube (570 Series); Venti-Trach Tracheostomy Tube (571 Series); Venti-Trach Tracheostomy Tube (580 Series); Venti-Trach Tracheostomy Tube (581 Series) (K253063): 510(k) cleared for Vitaltec Corporation
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Unlock Venti-Trach Tracheostomy Tube (570 Series); Venti-Trach Tracheostomy Tube (571 Series); Venti-Trach Tracheostomy Tube (580 Series); Venti-Trach Tracheostomy Tube (581 Series) (K253063): 510(k) cleared for Vitaltec + all 4 TW records (CSV)
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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: 2026-11-03
- 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: Venti-Trach Tracheostomy Tube (570 Series); Venti-Trach Tracheostomy Tube (571 Series); Venti-Trach Tracheostomy Tube (580 Series); Venti-Trach Tracheostomy Tube (581 Series) (K253063): 510(k) cleared for Vitaltec Corporation and 4 TW peers
- TW FDAPulse records like this one: 4
- Venti-Trach Tracheostomy Tube (570 Series); Venti-Trach Tracheostomy Tube (571 Series); Venti-Trach Tracheostomy Tube (580 Series); Venti-Trach Tracheostomy Tube (581 Series) (K253063): 510(k) cleared for Vitaltec Corporation's amount: 98th 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)
60 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- A long 354-day review suggests additional-information requests: a firm likely to value regulatory help next time.
- Special 510(k): a modification of an existing device.
What is the FDAPulse record for Venti-Trach Tracheostomy Tube (570 Series); Venti-Trach Tracheostomy Tube (571 Series); Venti-Trach Tracheostomy Tube (580 Series); Venti-Trach Tracheostomy Tube (581 Series) (K253063): 510(k) cleared for Vitaltec Corporation?
Venti-Trach Tracheostomy Tube (570 Series); Venti-Trach Tracheostomy Tube (571 Series); Venti-Trach Tracheostomy Tube (580 Series); Venti-Trach Tracheostomy Tube (581 Series) (K253063) by Vitaltec Corporation was cleared on 2026-09-11 after 354 days of review.
How does Venti-Trach Tracheostomy Tube (570 Series); Venti-Trach Tracheostomy Tube (571 Series); Venti-Trach Tracheostomy Tube (580 Series); Venti-Trach Tracheostomy Tube (581 Series) (K253063): 510(k) cleared for Vitaltec Corporation compare to other FDAPulse records?
This is a top-decile record: its amount of 354 is 2.6x the median of 138 across 414 records. It is 54 days old; check the official source for later updates before acting.
Venti-Trach Tracheostomy Tube (570 Series); Venti-Trach Tracheostomy Tube (571 Series); Venti-Trach Tracheostomy Tube (580 Series); Venti-Trach Tracheostomy Tube (581 Series) (K253063) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| Venti-Trach Tracheostomy Tube (570 Series); Venti-Trach Tracheostomy Tube (571 Series); Venti-Trach Tracheostomy Tube (580 Series); Venti-Trach Tracheostomy Tube (581 Series) (K253063) | TW | 2026-09-11 |
| BreathCare PAP III (YH-390N) (K260251) | CN | 2026-10-23 |
| Helo Return (K253717) | CA | 2026-10-11 |
| Aevice Wheeze Detection Module (K260140) | SG | 2026-09-25 |
Related records
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- Aevice Wheeze Detection Module (K260140): 510(k) cleared for Aevice Health Pte. , Ltd.
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Recent FDA 510(k) clearances FDA 510(k) clearances and recalls: Anesthesiology devices
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