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Hokanson E20

by D. E. Hokanson, Inc. 2 variants

Hokanson E20 (00597), a blood pressure cuff inflation regulator (FDA Class II; FDA product code DXN, System, Measurement, Blood-Pressure, Non-Invasive) made by D. E. Hokanson, Inc., was cleared under FDA 510(k) K905367 on 6 Mar 1991 and listed in FDA GUDID on 16 Sep 2016 (UDI-DI 00817065021259); the registry lists it as not in commercial distribution (GUDID) as of 22 Oct 2026.

Active United States. Also listed in GUDID (US), not in commercial distribution.

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K905367

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00817065021259 UDI-DI Date16 Sep 2016ListedStatusListed GUDID: not in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK905367 Date6 Mar 1991DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K905367 decided 6 Mar 1991 Active
  • FDA GUDID UDI-DI 00817065021259 listed 16 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K905367
  2. Listed FDA GUDID 00817065021259

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Hokanson
Generic name
Blood pressure cuff inflation regulator
Model / Ref / Catalog
E20, 00597
Primary DI / UDI-DI
00817065021259
510(k) Number
FDA product code
DXN
GMDN term
Blood pressure cuff inflation regulator
Device class
Class II
Regulation number
870.1130
GUDID distribution status
Not in Commercial Distribution

Related devices

Cleared under the same submission (K905367)

and 1 more cleared under K905367

Similar devices

Other devices filed under FDA product code DXN (System, Measurement, Blood-Pressure, Non-Invasive).

Other devices from D. E. Hokanson, Inc.

See all devices from D. E. Hokanson, Inc. →

Properties

  • Serial number
Other properties (14, all answered No)