E-Vac(Tm)

FDA 510(k) K862875 · Laerdal California, Inc.

Substantially Equivalent

510(k) numberK862875

Submission

Device name
E-Vac(Tm)
Applicant
Laerdal California, Inc.
Long Beach, CA, US
Received
July 30, 1986
Decision date
November 3, 1986
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

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

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K251450Baby Nasal Aspirator (BN002); Baby Nasal Aspirator (BN006); Baby Nasal Aspirator…BTA · Special Shenzhen Desida Technology Co., Ltd.06/06/2025SE
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More from Shenzhen Kingboom Technology Co., Ltd.

510(k)DeviceDecision
K941578Statvac Portable Suction UnitBTA · Traditional 05/18/1994SE
K922842Stylet and Tracheal Lightwand (STL)BSR · Traditional 12/18/1992SE
K843790Tracheal Tube Fixation DeviceCBH · Traditional 03/11/1985SE
K832990Stifnick Immobilizing CollarIQK · Traditional 11/07/1983SE

Questions and answers

When was E-Vac(Tm) cleared by the FDA?

E-Vac(Tm) (K862875) received a 510(k) decision of Substantially Equivalent on November 3, 1986, 96 days after the submission was received.

What is the product code of K862875?

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