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510(k) K201666

SINGLE USE MANOMETER by Flexicare Medical Limited. — Product Code CAP

K201666 is an FDA 510(k) premarket notification submitted by Flexicare Medical Limited. for the device "SINGLE USE MANOMETER". The FDA issued a decision of Substantially Equivalent on November 13, 2020. The device falls under product code CAP (Monitor, Airway Pressure (Includes Gauge And/Or Alarm)), a Class II device regulated under 21 CFR 868.2600. Flexicare Medical Limited. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 13, 2020
Date Received
June 19, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Airway Pressure (Includes Gauge And/Or Alarm)
Device Class
Class II
Regulation Number
868.2600
Review Panel
AN
Submission Type

Other clearances by Flexicare Medical Limited.

  • K251448 — FL-10000U Respiratory Humidifier (January 16, 2026)
  • K250243 — ProVu Single Use Video Stylet with Reinforced ET Tube (Size 6.5) (038-995-065U); (May 20, 2025)
  • K191909 — HepaShield Bacterial Viral Breathing System Filter (March 23, 2020)
  • K181583 — Adult Single Use Resuscitator Bag without Pressure Relief, Adult Single Use Resu (December 7, 2018)
  • K163300 — ThermoShield HME Filter (March 22, 2017)
  • K161314 — FLEXICARE FL-9000U RESPIRATORY HUMIDIFIER BASE (July 6, 2016)
  • K160540 — FLEXICARE NEONATAL HEATED WIRE BREATHING SYSTEM (June 23, 2016)

Other clearances for product code CAP

  • K182292 — VORTRAN APM-Plus (September 18, 2019)
  • K180510 — NS 120P-TRS Airway Pressure Gauge (May 1, 2019)
  • K172284 — NAPA LP-15 Airway Pressure Monitor (February 9, 2018)
  • K153733 — VORTRAN Manometer (September 16, 2016)
  • K143148 — Disposable Pressure Manometer (DPM) (August 11, 2015)
  • K140370 — DISPOSABLE PRESSURE MANOMETER (June 19, 2014)
  • K122627 — GIO DIGITAL PRESSURE GUAGES (August 22, 2013)
  • K122077 — MANOMETER (January 10, 2013)
  • K120118 — VENTLAB PRESSURECHEK DISOSABLE COLUMN MANOMETER (May 24, 2012)
  • K103639 — VORTRAN AIRWAY PRESSURE MONITOR (VAPM)-ADULT, VORTRAN AIRWAY PRESSURE MONITOR (V (September 15, 2011)

FDA data resources