Statvac Portable Suction Unit

FDA 510(k) K941578 · Laerdal California, Inc.

Substantially Equivalent

510(k) numberK941578

Submission

Device name
Statvac Portable Suction Unit
Applicant
Laerdal California, Inc.
Long Beach, CA, US
Received
March 31, 1994
Decision date
May 18, 1994
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
BTA – Pump, Portable, Aspiration (Manual Or Powered)
Device class
Class II (moderate risk)
Regulation
21 CFR 878.4780
Specialty
General, Plastic Surgery

Other 510(k)s with product code BTA

510(k)DeviceApplicantDecision
K253629Momcozy Nasal Aspirator (BN007)BTA · Traditional Shenzhen Root Innovation Technology Co., Ltd.05/26/2026SE
K260134Baby Nasal Aspirator (BN006, BN006-A, BN006-B, BN006-C, BN006-D, BN02; BN008, BN008-A…BTA · Traditional Shenzhen Root Innovation Technology Co., Ltd.05/15/2026SE
K260892Suction Pump (SU-90)BTA · Traditional Shenzhen HugeMed Medical Technical Development…05/14/2026SE
K260473Electric nasal aspirator (BC027, BC030, BC033, BC035, BC035B)BTA · Traditional Shenzhen Kingboom Technology Co., Ltd.05/12/2026SE
K253107Electric Nasal Aspirator (DT10 and DT50, DX80, DX85, DX86 and DX90)BTA · Traditional Shenzhen Dongjiang Technology Co., Ltd.04/14/2026SE
K260147Electric nasal aspirator (BC026, BC025, BC023, BC028, BC029, BC036)BTA · Traditional Shenzhen Kingboom Technology Co., Ltd.03/13/2026SE
K251450Baby Nasal Aspirator (BN002); Baby Nasal Aspirator (BN006); Baby Nasal Aspirator…BTA · Special Shenzhen Desida Technology Co., Ltd.06/06/2025SE
K244033Electric Nasal Aspirator (NASA601,NASA602,NASA603,NASA605,NASA606,NASA608,NASA610)BTA · Traditional Shenzhen Desida Technology Co., Ltd.05/16/2025SE
K251101AIRO Suction Unit (AIRO-01)BTA · Traditional Cro, LLC04/26/2025SE
K250697Electric Nasal Aspirator (BC026, BC025, BC023)BTA · Traditional Shenzhen Kingboom Technology Co., Ltd.04/23/2025SE

More from Shenzhen Kingboom Technology Co., Ltd.

510(k)DeviceDecision
K922842Stylet and Tracheal Lightwand (STL)BSR · Traditional 12/18/1992SE
K862875E-Vac(Tm)BTA · Traditional 11/03/1986SE
K843790Tracheal Tube Fixation DeviceCBH · Traditional 03/11/1985SE
K832990Stifnick Immobilizing CollarIQK · Traditional 11/07/1983SE

Questions and answers

When was Statvac Portable Suction Unit cleared by the FDA?

Statvac Portable Suction Unit (K941578) received a 510(k) decision of Substantially Equivalent on May 18, 1994, 48 days after the submission was received.

What is the product code of K941578?

The FDA product code is BTA – Pump, Portable, Aspiration (Manual Or Powered), a Class II (moderate risk) device regulated under 21 CFR 878.4780.