Suction Easy EMI610

by Em Innovations Inc

Suction Easy EMI610 is a Class I device made by Em Innovations Inc, cleared under FDA 510(k) K882017 on 14 Jul 1988 and listed in FDA GUDID since 20 Apr 2022 (UDI-DI 00860007555329), active as of 22 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

FDA submission, from GUDID

Trust

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00860007555329 UDI-DI	Date20 Apr 2022Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK882017	Date14 Jul 1988Decided	StatusActive

Official records

AccessGUDID record UDI-DI 00860007555329
FDA 510(k) database 510(k) number K882017

Across registries

2 registries list this device

FDA 510(k) K882017 decided 14 Jul 1988 Active
FDA GUDID UDI-DI 00860007555329 listed 20 Apr 2022 Listed

Timeline

2 dated events

14 Jul 1988 Cleared FDA 510(k) K882017
20 Apr 2022 Listed FDA GUDID 00860007555329

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Suction Easy
Generic name: Emergency airway clearance suction pump, manual
Model / reference: EMI610

Primary DI / UDI-DI: 00860007555329
510(k) Number: K882017
FDA product code: BSY
GMDN term: Emergency airway clearance suction pump, manual

Device class: Class I
Regulation number: 868.6810
GUDID distribution status: In Commercial Distribution

Similar devices

Other devices filed under FDA product code BSY (Catheters, Suction, Tracheobronchial).

Other devices from Em Innovations Inc

Suction Easy EMI610 CS

Class I
Seaduc EMI700

Class I

Properties

Single use
Lot / batch number

Other properties (13, all answered No)