FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
HUMIDI-FLEX TM
K Number: K885313
·
Decision Oct 11, 1989
Classifications
1
FEI Numbers
125
Registration Numbers
125
Same Product Code
72
Applicant Total
29
Review Days
286
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- HUMIDI-FLEX TM
- K Number
- K885313
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5375
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Life Design Systems, Inc.
- Date Received
- December 29, 1988
- Decision Date
- October 11, 1989
- Product Code
- BYD
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| BYD | Condenser, Heat And Moisture (Artificial Nose) | FDA class 1 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (BYD), ordered by most recent decision date.
HEAT & MOISTURE EXCHANGER
FDA 510(k)
FDA Class 1
·Anesthesiology
DISPOSABLE HME/FILTER
FDA 510(k)
FDA Class 1
·Anesthesiology
HEAT MOISTURE EXCHANGER
FDA 510(k)
FDA Class 1
·Anesthesiology
TYPE 1 & 2 (HUMIDAIR I & II)
FDA 510(k)
FDA Class 1
·Anesthesiology
HUMID-VENT 2 LIGHT/HUMID-VENT 2 PORT LIGHT
FDA 510(k)
FDA Class 1
·Anesthesiology
HUMID-VENT 1 PORT/HUMID-VENT 1 PORT ANGLE
FDA 510(k)
FDA Class 1
·Anesthesiology
Other Clearances by Life Design Systems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K913714 | MODIFICATION MANUAL PULMON RESUSCITOR/PULMANEX(TM) | Dec 1, 1992 | Substantially Equivalent |
| K893030 | CHILD SIZE - FILTER FLEX (TM) | Sep 18, 1989 | Substantially Equivalent |
| K892862 | FLEX-CUP PERCUSSOR | May 25, 1989 | Substantially Equivalent |
| K892221 | PULMONARY RESUSCITATOR, MODIFICATION | May 18, 1989 | Substantially Equivalent |
| K890011 | OXYGEN CONNECTOR AND OXYGEN DELIVERY TUBING | Mar 20, 1989 | Substantially Equivalent |
| K890108 | MODIFIED CUSHION-FLEX(TM) | Jan 24, 1989 | Substantially Equivalent |
| K884387 | CUSHION FLEX(TM) | Nov 17, 1988 | Substantially Equivalent |
| K884068 | PULMANEX TM (NEO-NATAL SIZE) | Nov 16, 1988 | Substantially Equivalent |
| K873179 | HEATER WIRE BREATHING CIRCUIT | Mar 31, 1988 | Substantially Equivalent |
| K863857 | PULSE-OX | Oct 7, 1987 | Substantially Equivalent |