Home / 510(k) Clearances / K013856

510(k) K013856

PMH 1000 HEATED HUMIDIFIER by Pegasus Research Corp. — Product Code BTT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 21, 2003
Date Received
November 6, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Humidifier, Respiratory Gas, (Direct Patient Interface)
Device Class
Class II
Regulation Number
868.5450
Review Panel
AN
Submission Type

Other clearances by Pegasus Research Corp.

  • K122857 — HOPE CONTINUOUS NEBULIZER MODEL HOPE-11310, HEART NEBULIZER MODEL HEART-100609, (November 7, 2012)
  • K020700 — PMH 5000 HEATED HUMIDIFIER FOR RESPIRATORY THERAPY (April 26, 2004)
  • K983783 — HEATED HUMIDIFIER (October 24, 2000)
  • K962534 — THERA-MIST NEBULIZER MODEL-P3000 (February 28, 1997)
  • K946057 — AQUALARM MOISTURE SENSOR MODEL P85000 (May 5, 1995)
  • K915890 — AUTOCLAVABLE THERA-MIST HUMIDIFIER P3600, MODIFIED (June 24, 1992)
  • K914465 — AUTOCLAVABLE VERSION THERA-MIST NEBULIZER, P32000 (March 31, 1992)
  • K903489 — THERA-MIST TM VOLUMINA INCENT SPIROMETER, P40000 (December 10, 1990)
  • K893942 — THERA-MIST(TM) NEBULIZER, MODEL 30000 (August 28, 1989)
  • K894000 — THERA-MIST HUMIDIFIER (August 28, 1989)

Other clearances for product code BTT

  • K251448 — FL-10000U Respiratory Humidifier (January 16, 2026)
  • K251419 — Laboratorios Biogalenic Sterile Water for Inhalation, USP (January 14, 2026)
  • K253479 — Optiflow Switch+ Filtered Nasal Interface with CO2 Sampling (AA042J) (December 19, 2025)
  • K250312 — Hudson RCI® Comfort Flo Nasal Cannula Premature, Infant; Hudson RCI® Comfort Flo (July 2, 2025)
  • K251611 — Optiflow+ Nasal Cannula - Small (OPT942); Optiflow+ Nasal Cannula - Medium (OPT (June 25, 2025)
  • K242717 — Laboratorios Biogalenic Sterile Water for Inhalation, USP (January 30, 2025)
  • K241778 — Hudson RCI Comfort Flo® CubCannula™ (December 19, 2024)
  • K240163 — Hudson RCI® Comfort Flo Nasal Cannula; Hudson RCI® Comfort Flo Plus Cannula (September 27, 2024)
  • K234058 — F&P Optiflow Filtered Nasal Interface with Anesthesia Mask Compatibility (AA041 (August 8, 2024)
  • K233707 — HFT150 (June 14, 2024)