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Suction Easy EMI610 CS

by Em Innovations Inc

Suction Easy EMI610 CS 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 10860007555326), active as of 23 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 23 Oct 2026

Documents

510(k) K882017

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10860007555326 UDI-DI Date20 Apr 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK882017 Date14 Jul 1988DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K882017 decided 14 Jul 1988 Active
  • FDA GUDID UDI-DI 10860007555326 listed 20 Apr 2022 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K882017
  2. Listed FDA GUDID 10860007555326

Coverage

1 jurisdiction

United States of America
  • 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  • Withdrawn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 CS
Primary DI / UDI-DI
10860007555326
510(k) Number
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

    Class I
  • Seaduc EMI700

    Class I

Properties

  • Single use
  • Lot / batch number
Other properties (13, all answered No)