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Sensoronics SFP-BCI-36I

by Sensoronics Incorporated

Sensoronics SFP-BCI-36I is a Class II device made by Sensoronics Incorporated, cleared under FDA 510(k) K113727 on 21 Mar 2013 and listed in FDA GUDID since 26 Sep 2016 (UDI-DI 00851456007347), 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) K113727

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 Number00851456007347 UDI-DI Date26 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) from GUDID NumberK113727 Date21 Mar 2013IssuedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K113727 decided 21 Mar 2013 Active
  • FDA GUDID UDI-DI 00851456007347 listed 26 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K113727
  2. Listed FDA GUDID 00851456007347

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Sensoronics
Generic name
Pulse oximeter probe, single-use
Model / reference
SFP-BCI-36I
Primary DI / UDI-DI
00851456007347
510(k) Number
FDA product code
DQA
GMDN term
Pulse oximeter probe, single-use
Device class
Class II
Regulation number
870.2700
GUDID distribution status
In Commercial Distribution

Related devices

Category: Pulse oximeter probe, single-use

Cleared under the same submission (K113727)

and 8 more cleared under K113727

Similar devices in this category

Other devices filed under Pulse oximeter probe, single-use.

Other devices from Sensoronics Incorporated

See all devices from Sensoronics Incorporated →

Properties

  • Single use
  • Contains latex
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (10, all answered No)