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510(k) K873448

FOLEY CATHETER TEMPERATURE SENSOR by Respiratory Support Products, Inc. — Product Code KOD

K873448 is an FDA 510(k) premarket notification submitted by Respiratory Support Products, Inc. for the device "FOLEY CATHETER TEMPERATURE SENSOR". The FDA issued a decision of Substantially Equivalent on December 7, 1987. The device falls under product code KOD (Catheter, Urological), a Class II device regulated under 21 CFR 876.5130. Respiratory Support Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 7, 1987
Date Received
August 26, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Urological
Device Class
Class II
Regulation Number
876.5130
Review Panel
GU
Submission Type

Other clearances by Respiratory Support Products, Inc.

  • K983862 — CLOUD 1 HUMIDIFICATION SYSTEM (May 24, 1999)
  • K921190 — ADAP-TEMP TEMPERATURE SENSOR ADAPTER (March 9, 1993)
  • K920469 — MYOCARDINAL TEMPERATURE SENSOR WITH TYPE 400 SERIE (September 11, 1992)
  • K921510 — GAS SAMPLING KIT MODIFICATION (June 11, 1992)
  • K913082 — BI-TEMP TEMPERATURE MONITOR,MODEL TM-300D (December 11, 1991)
  • K913083 — BI-TEMP TEMPERATURE MONITOR TM-201D (October 17, 1991)
  • K912280 — BI-TEMP TEMPERATURE MONITOR, MODEL TM-400D (October 17, 1991)
  • K903816 — URINE METER FOLEY TRAY WITH TEMPERATURE SENSOR (October 31, 1990)
  • K874694 — ADAP-TEMP, MODEL: AT-100 (March 1, 1988)
  • K873472 — MEMBRANE HUMIDIFIER (January 19, 1988)

Other clearances for product code KOD

  • K251864 — Rubber Utility Catheter (February 23, 2026)
  • K220036 — Wellead Ureteral Catheter (December 16, 2022)
  • K220730 — allFlex Ureteral Catheters, Krait Ureteral Catheters (October 13, 2022)
  • K211032 — Urinary Catheter 12 Fr, Urinary Catheter 16 Fr (November 19, 2021)
  • K181979 — Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent Catheter (May 24, 2019)
  • K180354 — UroGen Ureteral Catheter (October 30, 2018)
  • K181144 — Angled Tip Ureteral Catheter (June 28, 2018)
  • K180530 — Imager II Urology Torque Catheter (April 10, 2018)
  • K171810 — Cone Tip Ureteral Catheter, Rutner Universal Wedge Catheter (March 7, 2018)
  • K171600 — Renal Access Cobra Catheter, Kumpe Access Catheter (February 16, 2018)

FDA data resources