FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PER-FIT PERCUTANEOUS DILATIONAL TRACHEOSTOMY KIT
K Number: K031057
·
Decision Jul 18, 2003
Classifications
1
FEI Numbers
75
Registration Numbers
75
Same Product Code
108
Applicant Total
20
Review Days
106
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
- PER-FIT PERCUTANEOUS DILATIONAL TRACHEOSTOMY KIT
- K Number
- K031057
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5800
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Portex, Inc.
- Date Received
- April 3, 2003
- Decision Date
- July 18, 2003
- Product Code
- JOH
- 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 |
|---|---|---|---|
| JOH | Tube Tracheostomy And Tube Cuff | FDA class 2 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JOH), ordered by most recent decision date.
Shiley Adult Flexible Tracheostomy Tube XLT with TaperGuard Cuff, Distal with Disposable Inner Cannula; Shiley Adult Flexible Tracheostomy Tube XLT with TaperGuard Cuff, Proximal with Disposable Inner Cannula; Shiley Adult Flexible Tracheostomy Tube XLT Cuffless, Distal with Disposable Inner Cannula ; Shiley Adult Flexible Tracheostomy Tube XLT Cuffless, Proximal with Disposable Inner Cannula; Shiley Adult Flexible Disposable Inner Cannula XLT
FDA 510(k)
FDA Class 2
·Anesthesiology
Portex BLUxl Extra Length Tracheostomy Tube, BLUxl Suctionaid Extra Length Tracheostomy Tube, BLUxl Extra Length Tracheostomy Inner Cannula
FDA 510(k)
FDA Class 2
·Anesthesiology
TRACOE vario
FDA 510(k)
FDA Class 2
·Anesthesiology
Shiley Adult Flexible Evac Tracheostomy Tube with TaperGuard Cuff
FDA 510(k)
FDA Class 2
·Anesthesiology
Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Tray, Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray, Weinmann-Multi Percutaneous Tracheostomy Exchange Set
FDA 510(k)
FDA Class 2
·Anesthesiology
Shiley Neonatal/Pediatric Tracheostomy Tube
FDA 510(k)
FDA Class 2
·Anesthesiology
Other Clearances by Portex, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K033080 | PORTEX 24G PEDIATRIC EPIDURAL AND PERIPHERAL BLOCK ANESTHESIA CATHETER | Mar 10, 2004 | Substantially Equivalent |
| K023793 | 1ST RESPONSE INTERMEDIATE MANUAL RESUSCITATOR | Feb 11, 2003 | Substantially Equivalent |
| K014115 | 1ST RESPONSE MANUAL RESUSCITATOR, MODEL 85XX | Feb 27, 2002 | Substantially Equivalent |
| K014073 | HYPODERMIC NEEDLE-PRO INSULIN SYRINE & NEEDLE WITH NEEDLE PROTECTION DEVICE | Feb 13, 2002 | Substantially Equivalent |
| K873992 | LARYNGECTOMY TUBE | Mar 24, 1988 | Substantially Equivalent |
| K874597 | THERMOVENT 600, 1200, T, 02 | Jan 19, 1988 | Substantially Equivalent |
| K862167 | MINI-TRACH KIT | Aug 6, 1986 | Substantially Equivalent |
| K842456 | JET VENTILATION ADAPTOR | Jul 6, 1984 | Substantially Equivalent |
| K833908 | IRRI-CATH | Feb 4, 1984 | Substantially Equivalent |
| K840015 | SWIVEL ADAPTOR W/ALARM PORT | Jan 17, 1984 | Substantially Equivalent |