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Level 1 STS-201

by ICU Medical, Inc.

Level 1 STS-201 is a Class II device made by ICU Medical, Inc., cleared under FDA 510(k) K864195 on 19 Nov 1986 and listed in FDA GUDID since 11 Oct 2016 (UDI-DI 30695085000154), active as of 23 Oct 2026. 2 FDA recalls are 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

2 closed

Documents

510(k) K864195

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number30695085000154 UDI-DI Date11 Oct 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK864195 Date19 Nov 1986DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K864195 decided 19 Nov 1986 Active
  • FDA GUDID UDI-DI 30695085000154 listed 11 Oct 2016 Listed

Recalls

2 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-0768-06 FDA Unclassified (pre-2012) initiated 8 Mar 2006
    • Terminated Z-0767-06 FDA Unclassified (pre-2012) initiated 8 Mar 2006

    Product temperature readings may be 2C higher than the actual temperature

Timeline

4 dated events

  1. Cleared FDA 510(k) K864195
  2. Recall initiated FDA recalls Z-0768-06
  3. Recall initiated FDA recalls Z-0767-06
  4. Listed FDA GUDID 30695085000154

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Level 1
Generic name
General-purpose patient temperature probe, single-use
Model / reference
STS-201
Primary DI / UDI-DI
30695085000154
510(k) Number
FDA product code
FLL
GMDN term
General-purpose patient temperature probe, single-use
Device class
Class II
Regulation number
880.2910
GUDID distribution status
In Commercial Distribution

Related devices

Category: General-purpose patient temperature probe, single-use

Cleared under the same submission (K864195)

and 8 more cleared under K864195

Similar devices in this category

Other devices filed under General-purpose patient temperature probe, single-use.

Other devices from ICU Medical, Inc.

See all devices from ICU Medical, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)