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Real-Time 5138

by PENTAX of America Inc.

Real-Time 5138 is a Class II device made by PENTAX of America Inc., cleared under FDA 510(k) K990240 on 11 Mar 1999 and listed in FDA GUDID since 6 Apr 2017 (UDI-DI 04961333229796), active as of 8 Nov 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 8 Nov 2026

Documents

510(k) K990240

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 8 Nov 2026.

Regulatory status

as of registry sync 8 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number04961333229796 UDI-DI Date6 Apr 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK990240 Date11 Mar 1999DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K990240 decided 11 Mar 1999 Active
  • FDA GUDID UDI-DI 04961333229796 listed 6 Apr 2017 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K990240
  2. Listed FDA GUDID 04961333229796

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Real-Time
Generic name
Electroglottograph
Model / reference
5138
Primary DI / UDI-DI
04961333229796
510(k) Number
FDA product code
KLX
GMDN term
Electroglottograph
Device class
Class II
Regulation number
874.1325
GUDID distribution status
In Commercial Distribution

Related devices

Category: Electroglottograph

Cleared under the same submission (K990240)

Other devices from PENTAX of America Inc.

See all devices from PENTAX of America Inc. →

Properties

  • Single use
  • Prescription use
  • Lot / batch number
Other properties (12, all answered No)