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510(k) K895703

DIATEK MODEL 700 THERMOMETER by Diatek, Inc. — Product Code FLL

K895703 is an FDA 510(k) premarket notification submitted by Diatek, Inc. for the device "DIATEK MODEL 700 THERMOMETER". The FDA issued a decision of Substantially Equivalent on December 7, 1989. The device falls under product code FLL (Continuous Measurement Thermometer), a Class II device regulated under 21 CFR 880.2910. Diatek, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 7, 1989
Date Received
September 22, 1989
Clearance Type
Traditional
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 Diatek, Inc.

  • K020430 — DIATEK CONNECTOR ASSEMBLY REPLACEMENT KIT (CARK) (May 9, 2002)
  • K010399 — DIATEK CANNON-CATH #CC2400, CC2800, CC3200, CC3600,CC5500. CC2400PC, CC2800PC, C (August 14, 2001)
  • K872178 — MODIFICATION TO ARKIVE(TM) (January 27, 1988)
  • K862085 — ARKIVE (TM) (January 12, 1987)
  • K841827 — ENTEROPORT NUTRITION PUMP (July 27, 1984)
  • K841859 — SECURA SET (July 3, 1984)
  • K833568 — DIATEK 600 THERMOMETER SYSTEM (January 10, 1984)
  • K830565 — SECURA SET SECONDARY ADMIN. SET (March 9, 1983)
  • K830377 — SECURA SET PRIMARY ADMIN. SET (March 1, 1983)
  • K830355 — SECURA IV VOLUMETRIC INFUSION PUMP (March 1, 1983)

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