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510(k) K821310

ESPREE' ANESTHESIA BACTERIAL FILTER by Esp Plastics, Inc. — Product Code CAH

K821310 is an FDA 510(k) premarket notification submitted by Esp Plastics, Inc. for the device "ESPREE' ANESTHESIA BACTERIAL FILTER". The FDA issued a decision of Substantially Equivalent on June 11, 1982. The device falls under product code CAH (Filter, Bacterial, Breathing-Circuit), a Class II device regulated under 21 CFR 868.5260. Esp Plastics, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 11, 1982
Date Received
May 4, 1982
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 Esp Plastics, Inc.

  • K821311 — ESPREE' BREATHING CIRCUIT (W/ACCESS (May 21, 1982)
  • K821309 — ESPREE', BREATHING BAG (May 21, 1982)
  • K821308 — ESPREE' GUEDEL ESPREE BERMAN AIRWAY (May 21, 1982)

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