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510(k) K925388

LIFE SHIELD HEALTHCARE PRODUCTS BREATHING FILTER by Life Shield Healthcare Products, Inc. — Product Code CAH

K925388 is an FDA 510(k) premarket notification submitted by Life Shield Healthcare Products, Inc. for the device "LIFE SHIELD HEALTHCARE PRODUCTS BREATHING FILTER". The FDA issued a decision of Substantially Equivalent on May 11, 1993. The device falls under product code CAH (Filter, Bacterial, Breathing-Circuit), a Class II device regulated under 21 CFR 868.5260. Life Shield Healthcare Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 11, 1993
Date Received
October 26, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Filter, Bacterial, Breathing-Circuit
Device Class
Class II
Regulation Number
868.5260
Review Panel
HO
Submission Type

Other clearances by Life Shield Healthcare Products, Inc.

  • K932562 — GAS SAMPLING LINES AND CONNECTORS (July 23, 1993)
  • K932557 — HYPERINFLATION SYSTEM (July 22, 1993)
  • K932561 — GUEDEL AIRWAYS (July 22, 1993)
  • K932558 — ADULT ANESTHESIA BREATHING CIRCUIT (July 22, 1993)
  • K932560 — VOLUME VENTILATORS (July 22, 1993)
  • K932563 — VENTILATOR HOSES (July 16, 1993)
  • K932559 — MAPLESON D CIRCUITS (July 16, 1993)
  • K932197 — CUSTOM ANESTHESIA CIRCUITS (July 2, 1993)
  • K932196 — COAXIAL CIRCUITS (July 2, 1993)
  • K932191 — BREATHING BAGS (July 2, 1993)

Other clearances for product code CAH

  • K252643 — Iso-Gard Filter Straight; Humid-Vent Filter Compact Angled (May 15, 2026)
  • K251583 — Ambu® Virobac II® Exhalation Filter (April 30, 2026)
  • K241339 — Besmed Bacterial Filter and HMEF (November 14, 2024)
  • K222917 — Breathing circuit bacterial/viral filter (February 15, 2024)
  • K230483 — Passy Muir Tracheostomy Viral & Bacterial Airway Protection Filter (PM-APF15) (September 16, 2023)
  • K223258 — TNI Clear-Guard™ 3 angled breathing filter (1545020) (June 15, 2023)
  • K221472 — Filter and HME/Filter (February 8, 2023)
  • K221836 — Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar Plus (December 7, 2022)
  • K221250 — EasyOne Filter (November 22, 2022)
  • K210352 — GGM Breathing Circuit Bacterial Filter (March 27, 2022)

FDA data resources