Cleared Traditional

ASPIRATOR

K832274 · Wells Johnson Co. · General & Plastic Surgery
Oct 1983
Decision
100d
Days
Class 2
Risk

About This 510(k) Submission

K832274 is an FDA 510(k) clearance for the ASPIRATOR, a Pump, Portable, Aspiration (manual Or Powered) (Class II — Special Controls, product code BTA), submitted by Wells Johnson Co. (Mchenry, US). The FDA issued a Cleared decision on October 20, 1983, 100 days after receiving the submission on July 12, 1983. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4780.

Submission Details

510(k) Number K832274 FDA.gov
FDA Decision Cleared SESE
Date Received July 12, 1983
Decision Date October 20, 1983
Days to Decision 100 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary —

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