4010 Non Conductive Ventilator Circuit W/Bacterial

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K851529 ↗

FDA Product Code

CAI

Device Class

Class I

Regulation

21 CFR Part 868.5240

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• #3011 Pediatric Non-Conduct Anes Cir W/ Brea Bag

  Class I

  FDA 510(k) K852316 Active Cleared 15 Jul 1985

• 4000 Non Conductive Anesthesia Ventilator Circuit

  Class I

  FDA 510(k) K853344 Active Cleared 29 Aug 1985

• 3015 Pediatric Non-Conductive Anesthesia Circuit W

  Class I

  FDA 510(k) K853343 Active Cleared 29 Aug 1985

• 4013 Non Conductive Anesth. Circuit W/Breath-Bag

  Class I

  FDA 510(k) K851531 Active Cleared 25 Apr 1985

• 4003 Non Conductive Anesthesia Circuit W/Breat\gas

  Class I

  FDA 510(k) K851530 Active Cleared 25 Apr 1985

• #3005 Pediatric Non-Conduct Anes Cir W/ Brea Bag

  Class I

  FDA 510(k) K852312 Active Cleared 15 Jul 1985

See all devices from Sigma Medical, Inc. →