VDR SINUSOIDAL PERCUSIONATOR FAMILY/RELATE ACCESS— 510(k) K905235
Substantially EquivalentPercussionaire Corp.
FDA 510(k) clearance K905235 for VDR SINUSOIDAL PERCUSIONATOR FAMILY/RELATE ACCESS, Substantially Equivalent on 1991-05-03. Applicant: Percussionaire Corp.. Device class: 2.
Clearance details
- Applicant
- Percussionaire Corp.
- Product code
- Code CBK
- Device class
- Class 2
- Regulation
- 21 CFR 868.5895
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Sandpoint, ID, US
Recent devices under product code CBK
view allMore clearances from Percussionaire Corp.
view allAdverse events under product code CBK
product code CBK- Death
- 736
- Injury
- 3,628
- Malfunction
- 98,786
- Other
- 4
- Total
- 103,154
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 K905235
K-number listed on FDA's recall record- Z-0960-2025 — VDR4 Phasitron Breathing Circuit Models that contain the venturi component: -A50094 D 5PK, Phasitron Kit, VDR, Single Patient, 5pk -A51001, VDR4 Control Unit Tester -PRT 991, VDR W/SWIVEL T SINGLE PATIENT PHASITRON -PRT 992, VDR4 HUMIDIFICATION ADAPTER KIT, CASE OF 10 -PRT 993, VDR4 Humidification Kit with Cross Tee, Case of 10 The Phasitron breathing circuit kit is intended to be used for continuous ventilation intended for controlled ventilation of patients
- Z-0693-2024 — Distal Phasitron, Part: S20020, for use with Percussionaire VDR-4 control driver (or control unit)
- Z-0259-2024 — Monitron II Waveform Analyzer, REF: S00015-1, used with ventilators.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K905235.
Data sourced from openFDA. This site is unofficial and independent of the FDA.