AMBU UNIVERSAL SUCTION PUMP— 510(k) K792592

Name: FDA 510(k) clearance K792592
Creator: U.S. Food and Drug Administration
Published: 1980-01-11

Substantially Equivalent

Narco Air-Shields

FDA 510(k) clearance K792592 for AMBU UNIVERSAL SUCTION PUMP, Substantially Equivalent on 1980-01-11. Applicant: Narco Air-Shields. Device class: 2.

Clearance details

Applicant: Narco Air-Shields
Product code: Code JCX
Device class: Class 2
Regulation: 21 CFR 878.4780
Advisory panel: General, Plastic Surgery
Date received: 1979-12-17
Decision date: 1980-01-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JCX

view all

K250964 — Protable Phlegm Suction Unit (JMA D01)2026-05-11
K243638 — MV Flow Aspiration Pump (MVFLOWPMP01)2025-06-13
K251111 — Cary2025-05-07
K243418 — Riptide Aspiration Pump; Riptide Collection Canister with Intermediate Tubing2024-12-02
K233428 — Easycess Aspiration Pump2023-11-03

More clearances from Narco Air-Shields

view all

K820114 — SYSTEM V.HEART RATE/RESPIR. RATE MONIT.1982-02-12
K810953 — MODEL 533 PHOTOTHERAPY UNIT1981-04-23
K810474 — PROBE COVER1981-03-31
K802800 — NARCO AIR-SHEILDS SYS. 100 MONITOR SYS1980-11-24
K802126 — ISOLETTE INCUBATOR C-1001980-09-26

Adverse events under product code JCX

product code JCX

Death: 11
Malfunction: 838
Other: 1
Total: 850

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.