RESUS-AID DISPOSABLE RESUSCITATION SHIELD— 510(k) K852096

Name: FDA 510(k) clearance K852096
Creator: U.S. Food and Drug Administration
Published: 1985-07-08

Substantially Equivalent

Emergency Situation Products

FDA 510(k) clearance K852096 for RESUS-AID DISPOSABLE RESUSCITATION SHIELD, Substantially Equivalent on 1985-07-08. Applicant: Emergency Situation Products. Device class: 2.

Clearance details

Applicant: Emergency Situation Products
Product code: Code BTM
Device class: Class 2
Regulation: 21 CFR 868.5915
Advisory panel: Anesthesiology
Date received: 1985-05-14
Decision date: 1985-07-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Memphis, TN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code BTM

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K251631 — The BAG manual resuscitator and accessories2025-11-24
K243861 — butterflyBVM2025-04-25
K221841 — EOlife®2023-03-18
K212905 — Sotair Device2022-08-18
K210288 — Disposable Manual Resuscitator2021-08-26

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K852095 — ESP EMERGENCY CARE KIT1985-07-11

Adverse events under product code BTM

product code BTM

Death: 19
Other: 2
Total: 21

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.