Cleared Traditional

ASPIRATOR, CONTINUOUS & PROGRAMMABLE INTERMITTENT

K951423 · Impact Instrumentation, Inc. · General & Plastic Surgery
Apr 1995
Decision
22d
Days
Class 2
Risk

About This 510(k) Submission

K951423 is an FDA 510(k) clearance for the ASPIRATOR, CONTINUOUS & PROGRAMMABLE INTERMITTENT, a Pump, Portable, Aspiration (manual Or Powered) (Class II — Special Controls, product code BTA), submitted by Impact Instrumentation, Inc. (West Caldwell, US). The FDA issued a Cleared decision on April 18, 1995, 22 days after receiving the submission on March 27, 1995. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4780.

Submission Details

510(k) Number K951423 FDA.gov
FDA Decision Cleared SESE
Date Received March 27, 1995
Decision Date April 18, 1995
Days to Decision 22 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement

Device Classification

Product Code BTA — Pump, Portable, Aspiration (manual Or Powered)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.4780

Similar Devices — BTA Pump, Portable, Aspiration (manual Or Powered)

All 152
Baby Nasal Aspirator (BN002); Baby Nasal Aspirator (BN006); Baby Nasal Aspirator (BN007); Baby Nasal Aspirator (BN008); Baby Nasal Aspirator (BN009)
K251450 · Shenzhen Desida Technology Co., Ltd. · Jun 2025
Electric Nasal Aspirator (NASA601,NASA602,NASA603,NASA605,NASA606,NASA608,NASA610)
K244033 · Shenzhen Desida Technology Co., Ltd. · May 2025
AIRO Suction Unit (AIRO-01)
K251101 · Cro, LLC · Apr 2025
Electric Nasal Aspirator (BC026, BC025, BC023)
K250697 · Shenzhen Kingboom Technology Co., Ltd. · Apr 2025
ATMOS C 051 Thorax (317.0200.0); Secretion canister 800ml (317.1300.0); Hose system (312.1177.0); Hose system with connector small (312.1206.0); Hose system with connector medium (312.1207.0); Hose system with connector large (312.1208.0); Hose system with Y-connector medium (312.1209.0); Hose system with Y-connector large (312.1210.0); Universal bracket for ATMOS C 051 Thorax (316.0200.0); Bracket for ATMOS C 051 Thorax - Standard rail (317.1160.0); Charger Storage for bracket ATMOS C
K241799 · Atmos Medizintechnik GmbH & Co. KG · Mar 2025
Geon (S2) Nasal Aspirator
K243138 · Geon Corporation · Feb 2025