Tec 820, Tec 850— 510(k) K172702
Substantially EquivalentDatex-Ohmeda, Inc.
FDA 510(k) clearance K172702 for Tec 820, Tec 850, Substantially Equivalent on 2018-01-04. Applicant: Datex-Ohmeda, Inc.. Device class: 2.
Clearance details
- Applicant
- Datex-Ohmeda, Inc.
- Product code
- Code CAD
- Device class
- Class 2
- Regulation
- 21 CFR 868.5880
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Madison, WI, US
Recent devices under product code CAD
view allMore clearances from Datex-Ohmeda, Inc.
view allAdverse events under product code CAD
product code CAD- Malfunction
- 3,275
- Total
- 3,275
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K172702
K-number listed on FDA's recall record- Z-0815-2025 — Tec 820 ISO Anesthesia Vaporizer, Reference Number 1177-9820-ISO
- Z-0816-2025 — Tec 820 SEV Anesthesia Vaporizer, Reference Number 1177-9820-SEV
- Z-0817-2025 — Tec 850 ISO Anesthesia Vaporizer, Reference Number 1177-9850-ISO
- Z-0818-2025 — Tec 850 SEV Anesthesia Vaporizer, Reference Number 1177-9850-SEV
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K172702.
Data sourced from openFDA. This site is unofficial and independent of the FDA.