BABI*PLUS PRESSURE RELIEF MANIFOLD - 10CM H20, 12.5CM H20, 15CM H20— 510(k) K110383
Substantially EquivalentA Plus Medical
FDA 510(k) clearance K110383 for BABI*PLUS PRESSURE RELIEF MANIFOLD - 10CM H20, 12.5CM H20, 15CM H20, Substantially Equivalent on 2011-08-01. Applicant: A Plus Medical. Device class: 2.
Clearance details
- Applicant
- A Plus Medical
- Product code
- Code BZD
- Device class
- Class 2
- Regulation
- 21 CFR 868.5905
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Carlsbad, CA, US
Recent devices under product code BZD
view allMore clearances from A Plus Medical
view all- K112852 — BABI PLUS NEONATAL RESUSCITATION BAG
- K110471 — BABI PLUS INFANT NASAL CANNULA SYSTEM
- K102377 — VENTIPLUS DISPOSABLE MANOMETER 0-60 CM H2O; VENTIPLUS DISPOSABLE MANOMETER 0-20 CM H2O
- K093716 — BABI PLUS INFANT NASAL CANNULA SYSTEM
- K092687 — VENTI.PLUS HYPERINFLATION BAG SYSTEM WITH PRESSURE MANOMETER
Adverse events under product code BZD
product code BZD- Death
- 4,440
- Injury
- 53,099
- Malfunction
- 213,222
- Other
- 17
- Total
- 270,778
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 K110383
K-number listed on FDA's recall record- Z-0009-2020 — Babi.Plus 12.5 cm H2O Pressure Relief Manifold Catalog # 2691 for use with ventilators.
- Z-0020-2020 — Babi.Plus 12.5 cm H2O Pressure Relief Manifold, REF 1030, RX Only, UDI: 04710810093562
- Z-0021-2020 — Babi.Plus Bubble PAP Valve with 12.5 cm H2O Pressure Relief Manifold, REF 1002, Rx Only, UDI: 24710810093559
- Z-0022-2020 — Babi.Plus 12.5 cm H2O Pressure Relief Manifold with Gas Supply Tube and Oxygen Sensor Port, REF 2691, Rx Only, UDI: 04710810100802
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K110383.
Data sourced from openFDA. This site is unofficial and independent of the FDA.