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RNK Products PPA/BT-RB

by Rnk Products, Inc.

RNK Products PPA/BT-RB is a Class II device made by Rnk Products, Inc., cleared under FDA 510(k) K132405 on 11 Oct 2013 and listed in FDA GUDID since 31 Aug 2016 (UDI-DI 00677986001019), 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

510(k) K132405

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 Number00677986001019 UDI-DI Date31 Aug 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK132405 Date11 Oct 2013DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K132405 decided 11 Oct 2013 Active
  • FDA GUDID UDI-DI 00677986001019 listed 31 Aug 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K132405
  2. Listed FDA GUDID 00677986001019

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
RNK Products
Generic name
Electronic acoustic stethoscope
Model / reference
PPA/BT-RB
Primary DI / UDI-DI
00677986001019
510(k) Number
FDA product code
DQD
GMDN term
Electronic acoustic stethoscope
Device class
Class II
Regulation number
870.1875
GUDID distribution status
In Commercial Distribution

Related devices

Category: Electronic acoustic stethoscope

Cleared under the same submission (K132405)

Similar devices in this category

Other devices filed under Electronic acoustic stethoscope.

Other devices from Rnk Products, Inc.

See all devices from Rnk Products, Inc. →

Properties

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