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Finapres PP Height Correction Unit

by Finapres Medical Systems B.V.

Finapres PP Height Correction Unit (FP_903902) is a Class II device made by Finapres Medical Systems B.V., cleared under FDA 510(k) K160967 on 18 Apr 2017 (2 earlier submissions) and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 08719327003640), active as of 23 Oct 2026. One FDA recall is linked to it.

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

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK160967 Date18 Apr 2017DecidedStatusActive
United StatesGUDID listing Number08719327003640 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • FDA 510(k) K160967 decided 18 Apr 2017 Active· +2 more in the status table
  • FDA GUDID UDI-DI 08719327003640 listed 24 Sep 2016 Listed

Recalls

1 recall · FDA

    • Terminated Z-2150-2012 FDA Class II initiated 6 Jul 2012

    Battery may become hot and leak

Timeline

5 dated events

  1. Cleared FDA 510(k) K023338
  2. Recall initiated FDA recalls Z-2150-2012
  3. Cleared FDA 510(k) K141460
  4. Listed FDA GUDID 08719327003640
  5. Cleared FDA 510(k) K160967

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Finapres
Generic name
Patient monitoring system module, blood pressure, noninvasive
Model / Ref / Catalog
PP Height Correction Unit, FP_903902
Primary DI / UDI-DI
08719327003640
510(k) Number
FDA product code
DSB, DXN
GMDN term
Patient monitoring system module, blood pressure, noninvasive
Device class
Class II
Regulation number
870.2770, 870.1130
GUDID distribution status
In Commercial Distribution

Related devices

Category: Patient monitoring system module, blood pressure, noninvasive

Cleared under the same submission (K023338)

and 2 more cleared under K023338

Cleared under the same submission (K141460)

and 1 more cleared under K141460

Similar devices in this category

Other devices filed under Patient monitoring system module, blood pressure, noninvasive.

Other devices from Fms, Finapres Medical Systems BV

See all devices from Fms, Finapres Medical Systems BV →

Properties

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