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510(k) K081805

CUFFALERT by Sunmed — Product Code BSK

K081805 is an FDA 510(k) premarket notification submitted by Sunmed for the device "CUFFALERT". The FDA issued a decision of Substantially Equivalent on November 14, 2008. The device falls under product code BSK (Cuff, Tracheal Tube, Inflatable), a Class II device regulated under 21 CFR 868.5750. Sunmed has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 14, 2008
Date Received
June 26, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cuff, Tracheal Tube, Inflatable
Device Class
Class II
Regulation Number
868.5750
Review Panel
AN
Submission Type

Other clearances by Sunmed

  • K233098 — MYOTouch Muscle Stimulator (August 2, 2024)
  • K121743 — EASYMED PERIPHERAL NERVE STIMULATOR-SUNSTIN (March 28, 2013)
  • K062112 — SUNMED FOLEY CATHETERS (June 4, 2007)
  • K955631 — ORTHOPLUG HARD BONE DESIGN (February 27, 1996)
  • K955632 — ORTHOPLUG SOFT BONE DESIGN (February 27, 1996)
  • K921263 — SUNLITE LARYNGOSCOPE (June 1, 1993)

Other clearances for product code BSK

  • K243562 — CuffGuard (August 12, 2025)
  • K242642 — CuffTrek (March 7, 2025)
  • K220854 — TrachCuff Cuff Controller (April 14, 2023)
  • K221477 — AG100s (December 29, 2022)
  • K202874 — Puritan Bennett Cuff Pressure Manager (January 9, 2021)
  • K192611 — Cuffix (August 13, 2020)
  • K191858 — Pylant Monitor (February 24, 2020)
  • K182548 — Accucuff Cuff Pressure Indicator (January 25, 2019)
  • K180991 — AG 100s (October 12, 2018)
  • K173914 — VORTRAN Cuff Inflator (VCI) (May 25, 2018)

FDA data resources