Home / 510(k) Clearances / K093716

510(k) K093716

BABI PLUS INFANT NASAL CANNULA SYSTEM by A Plus Medical — Product Code BZD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 13, 2010
Date Received
December 2, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ventilator, Non-Continuous (Respirator)
Device Class
Class II
Regulation Number
868.5905
Review Panel
AN
Submission Type

Other clearances by A Plus Medical

  • K112852 — BABI PLUS NEONATAL RESUSCITATION BAG (January 13, 2012)
  • K110471 — BABI PLUS INFANT NASAL CANNULA SYSTEM (October 7, 2011)
  • K110383 — BABI*PLUS PRESSURE RELIEF MANIFOLD - 10CM H20, 12.5CM H20, 15CM H20 (August 1, 2011)
  • K102377 — VENTIPLUS DISPOSABLE MANOMETER 0-60 CM H2O; VENTIPLUS DISPOSABLE MANOMETER 0-20 (November 18, 2010)
  • K092687 — VENTI.PLUS HYPERINFLATION BAG SYSTEM WITH PRESSURE MANOMETER (November 23, 2009)
  • K090317 — BABI*PLUS BUBBLE PAP VALVE (May 20, 2009)

Other clearances for product code BZD

  • K251847 — Sleepnet Arie Full Face Vented Mask; Sleepnet Arie Nasal Vented Mask (January 15, 2026)
  • K253939 — DeltaWave Nasal Pillow System (January 7, 2026)
  • K251770 — SleepRes PAP System (December 15, 2025)
  • K251657 — Personalized Therapy Comfort Settings (PTCS) (December 5, 2025)
  • K243583 — F&P Nova Nasal Mask (June 18, 2025)
  • K250624 — myAir (May 28, 2025)
  • K243023 — WiZARD 520 Full Face Mask (May 23, 2025)
  • K242547 — AirFit F20 Mask System; AirFit F20 NM Mask System (May 19, 2025)
  • K242935 — Respiration Data Management Software (PAP Link PC) (January 15, 2025)
  • K243225 — Nasal Pillow Mask - Small (NNPM-01/ Nefes S); Nasal Pillow Mask - Medium (NNPM-0 (December 31, 2024)