IMPACT, MODEL 302— 510(k) K820331

Name: FDA 510(k) clearance K820331
Creator: U.S. Food and Drug Administration
Published: 1982-02-23

Substantially Equivalent

Impact Instrumentation, Inc.

FDA 510(k) clearance K820331 for IMPACT, MODEL 302, Substantially Equivalent on 1982-02-23. Applicant: Impact Instrumentation, Inc.. Device class: 2.

Clearance details

Applicant: Impact Instrumentation, Inc.
Product code: Code JCX
Device class: Class 2
Regulation: 21 CFR 878.4780
Advisory panel: General, Plastic Surgery
Date received: 1982-02-08
Decision date: 1982-02-23
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 Impact Instrumentation, Inc.

view all

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 →

Recalls naming K820331

K-number listed on FDA's recall record

Z-2430-2012 — Model 324JL On-Board Suction System Intended use: On-board suction system for Ambulance manufacturers.Class III·Terminated·Impact Instrumentation, Inc.·20120330

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K820331.

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