Submission Details
| 510(k) Number | K020700 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 04, 2002 |
| Decision Date | April 26, 2004 |
| Days to Decision | 784 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Statement |
Cleared
Traditional
PMH 5000 HEATED HUMIDIFIER FOR RESPIRATORY THERAPY
Apr 2004
Decision
784d
Days
Class 2
Risk
About This 510(k) Submission
K020700 is an FDA 510(k) clearance for the PMH 5000 HEATED HUMIDIFIER FOR RESPIRATORY THERAPY, a Humidifier, Respiratory Gas, (direct Patient Interface) (Class II — Special Controls, product code BTT), submitted by Pegasus Research Corp. (Santa Ana, US). The FDA issued a Cleared decision on April 26, 2004, 784 days after receiving the submission on March 4, 2002. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5450.
Device Classification
| Product Code | BTT — Humidifier, Respiratory Gas, (direct Patient Interface) |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 868.5450 |
Manufacturer
Similar Devices — BTT Humidifier, Respiratory Gas, (direct Patient Interface)
All 219
K251448 · Flexicare Medical Limited.
· Jan 2026
K251419 · Laboratorios Biogalenic S.A. DE C.V.
· Jan 2026
K253479 · Fisher &Paykel Healthcare , Ltd.
· Dec 2025
K250312 · Medline Industries, LP
· Jul 2025
K251611 · Fisher &Paykel Healthcare , Ltd.
· Jun 2025
K242717 · Laboratorios Biogalenic S.A. DE C.V.
· Jan 2025
More from Pegasus Research Corp.
View all
K122857
· CAF · Nov 2012
K013856
· BTT · Feb 2003
K983783
· BTT · Oct 2000
K962534
· CAF · Feb 1997
K946057
· BYH · May 1995