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510(k) K180714

Probe Covers for Thermometers by K-Jump Health Co., Ltd. — Product Code FLL

K180714 is an FDA 510(k) premarket notification submitted by K-Jump Health Co., Ltd. for the device "Probe Covers for Thermometers". The FDA issued a decision of Substantially Equivalent on September 24, 2018. The device falls under product code FLL (Continuous Measurement Thermometer), a Class II device regulated under 21 CFR 880.2910. K-Jump Health Co., Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 24, 2018
Date Received
March 19, 2018
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Continuous Measurement Thermometer
Device Class
Class II
Regulation Number
880.2910
Review Panel
HO
Submission Type

A continuous measurement thermometer is a clinical electronic thermometer indicated to measure the body or skin temperature of a person continuously or in specified intervals. Under this regulation, this product code represents non-exempt devices. For more information, see 90 FR 25889, available at https://www.govinfo.gov/content/pkg/FR-2025-06-18/pdf/2025-11207.pdf.

Other clearances by K-Jump Health Co., Ltd.

  • K170262 — Digital Thermometer (September 28, 2017)
  • K141505 — BASAL DIGITAL THERMOMETER (August 26, 2014)
  • K121520 — ULTRASONIC NEBULIZER (MESH TYPE) (March 15, 2013)
  • K120711 — NON-CONTACT THERMOMETER (November 19, 2012)
  • K103617 — DIGITAL FOREHEAD THERMOMETER (April 4, 2011)
  • K102947 — NON-CONTACT INFRARED THERMOMETER (February 25, 2011)
  • K092335 — PEAK EXPIRATORY FLOW METER, KN-9710 (April 9, 2010)
  • K092806 — AUTO DIGITAL UPPER ARM BLOOD PRESSURE MONITOR, MODEL KP-7770 (October 9, 2009)
  • K083256 — ULTRASONIC NEBULIZER SYSTEM, MODEL KN-9210 (June 26, 2009)
  • K083753 — SMART-LOGIC AUTO DIGITAL UPPERARM BLOOD PRESSURE MONITOR, MODEL KP-7500, FULLY F (June 19, 2009)

Other clearances for product code FLL

  • K253162 — Temperature probes (T2252-PG); Temperature probes (TCMA-AG); Temperature probes (June 5, 2026)
  • K251160 — Sterile temperature probe (Model: W0001ES, W0028ES, W0101FS-A, W0101FS-P, W0099L (January 8, 2026)
  • K250470 — Ear Thermometer (EAR-E101); Ear Thermometer (EAR-E102); Ear Thermometer (EAR-E10 (June 23, 2025)
  • K243000 — Reusable Temperature Probe (T1306, T2306, T3306, T4306); Disposable Temperature (June 20, 2025)
  • K250878 — YUWELL® Infrared Ear Thermometer (YHT100); YUWELL® Infrared Ear Thermometer (YHT (May 22, 2025)
  • K243082 — Infrared Thermometer (April 25, 2025)
  • K250401 — AION TempShield™ (March 14, 2025)
  • K243136 — Non-contact Forehead Infrared Thermometer (FC-IR2000, FC-IR205, FC-IR202, FC-IR2 (February 14, 2025)
  • K240333 — Wearable Digital Thermometer (T31) (October 30, 2024)
  • K240223 — FMT Disposable and Autoclavable Temperature Probes (October 25, 2024)

FDA data resources