PEEP VALVE— 510(k) K923618
Substantially EquivalentInternational Respiratory Systems, Inc.
FDA 510(k) clearance K923618 for PEEP VALVE, Substantially Equivalent on 1992-08-03. Applicant: International Respiratory Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- International Respiratory Systems, Inc.
- Product code
- Code BYE
- Device class
- Class 2
- Regulation
- 21 CFR 868.5965
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Newburgh, NY, US
Recent devices under product code BYE
view allMore clearances from International Respiratory Systems, Inc.
view allAdverse events under product code BYE
product code BYE- Death
- 5
- Total
- 5
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 K923618
K-number listed on FDA's recall record- Z-2434-2020 — Neo-Vent Infant T-Piece Resuscitation Circuit;Circuit for use on compatible Infant Resuscitators. 15mm OD x 10mm ID connector; REF 0415, Qty:10, Length: 60" (1.5cm), Rx Only.
- Z-2435-2020 — Neo-Vent Infant T-Piece Resuscitation Circuit With Infant Mask; Circuit for use on compatible Infant Resuscitators. 15mm OD x 10mm ID connector; REF 0420, Qty:10, Length: 60" (1.5cm), Rx Only.
- Z-2436-2020 — Neo-Vent Infant T-Piece Resuscitation Circuit With Neonatal Mask; Circuit for use on compatible Infant Resuscitators. 15mm OD x 10mm ID connector; REF 0421, Qty:10, Length: 60" (1.5cm), Rx Only.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K923618.
Data sourced from openFDA. This site is unofficial and independent of the FDA.