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510(k) K871465

THERMOMETER SHEATHS by Abco Dealers, Inc. — Product Code FLL

K871465 is an FDA 510(k) premarket notification submitted by Abco Dealers, Inc. for the device "THERMOMETER SHEATHS". The FDA issued a decision of Substantially Equivalent on May 11, 1987. The device falls under product code FLL (Continuous Measurement Thermometer), a Class II device regulated under 21 CFR 880.2910. Abco Dealers, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 11, 1987
Date Received
April 14, 1987
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 Abco Dealers, Inc.

  • K905025 — DIGITAL THERMOMETER KITS (February 7, 1991)
  • K882304 — DIGITAL THERMOMETER SHEATHS (ORAL AND RECTAL) (July 12, 1988)
  • K880892 — BLOOD COLLECTING NEEDLE AND HOLDERS (April 21, 1988)
  • K880894 — ALLERGIST SYRINGES (March 31, 1988)
  • K872875 — STRETCH GAUZE BANDAGES (September 4, 1987)
  • K872874 — MICROSCOPE COVER GLASSES (August 10, 1987)
  • K872797 — NON-SKID SHOE COVERS (August 4, 1987)
  • K862726 — DISPOSABLE SHOE COVERS AND NURSES CAPS (August 1, 1986)
  • K862111 — ARMBOARDS, REUSABLE AND DISPOSABLE (July 8, 1986)
  • K862112 — MICROSCOPE SLIDES (June 13, 1986)

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