Airway, Nasopharyngeal
The Airway, Nasopharyngeal is a soft, flexible tube inserted through a nostril into the nasopharynx to maintain a patent airway in patients who may have partial upper airway obstruction or reduced consciousness. It is classified as FDA Class 1, the lowest risk category, subject to general controls only with no premarket submission required. The product code is BTQ, regulated under 21 CFR 868.5100 in the Anesthesiology specialty.
Basic Information
- Product Code
- BTQ
- Device Class
- FDA class 1
- Regulation Number
- 868.5100
- Medical Specialty
- Anesthesiology
- Review Panel
- AN
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 19 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K940320 | AD-TECH'S RAAB INFANT NASOPHARYNGEAL PRONGS | Sep 19, 1995 | Substantially Equivalent | AD-TECH MEDICAL INSTRUMENT CORP. |
| K921353 | NASOPHARYNGEAL AIRWAY | Jun 11, 1992 | Substantially Equivalent | COAST MEDICAL CORP. |
| K911784 | NORTEC ROBERTAZZI NASOPHARYNGEAL AIRWAY | Sep 23, 1991 | Substantially Equivalent | NORTH AMERICAN STERILIZATION & PACKAGING CO. |
| K903618 | ROBERTAZZI NASOPHARYNGEAL AIRWAY | Jan 08, 1991 | Substantially Equivalent | EASTMED ENTERPRISES INC. |
| K900456 | POLAMEDCO NASOPAHARYNGEAL AIRWAY | Apr 19, 1990 | Substantially Equivalent | POLAMEDCO, INC. |
| K901279 | CHATHAM INDUSTRIES NASOPHARYNGEAL AIRWAY | Mar 28, 1990 | Substantially Equivalent | CHATHAM INDUSTRIES |
| K883668 | SUNDERLAND NASAL TUBE | Nov 21, 1988 | Substantially Equivalent | EXMOOR PLASTICS LTD. |
| K873949 | RORERTAZZI NASOPHARYNGEAL AIRWAY | Oct 20, 1987 | Substantially Equivalent | PENN MEDICAL DEVICES, INC. |
| K871673 | NASOPHARYNGEAL AIRWAY | Jun 15, 1987 | Substantially Equivalent | HARDING INDUSTRIES, INC. |
| K853162 | STERILE NASOPHARYNGEAL AIRWAY | Aug 06, 1985 | Substantially Equivalent | INMED CORP. |
| K850644 | NASOPHARYNGEAL AIRWAY-ROBERTAZZI | Mar 21, 1985 | Substantially Equivalent | DRYDEN CORP. |
| K843524 | LINDER NASOPHARYNGEAL AIRWAY | Oct 04, 1984 | Substantially Equivalent | POLAMEDCO, INC. |
| K841093 | NASOPHARYNGEAL AIRWAYS | Mar 23, 1984 | Substantially Equivalent | INMED CORP. |
| K834078 | SILICONE RUGGER DISPOSABLE YOKE-CPAP | Dec 27, 1983 | Substantially Equivalent | VESTA, INC. |
| K831476 | NASOPHARYNGEAL AIRWAY-ROBERTAZZI STYLE | Jun 10, 1983 | Substantially Equivalent | FLS MEDICAL PRODUCTS, INC. |
| K830983 | AIRWAYS & NASOPHARYNGEAL TYPE | May 09, 1983 | Substantially Equivalent | MEDOVATIONS, INC. |
| K810960 | NASOPHARYNGEAL AIRWAY | Apr 23, 1981 | Substantially Equivalent | VESTA, INC. |
| K792018 | SILICONE RUBBER-BI NASOPHARYNGEAL AIR | Nov 13, 1979 | Substantially Equivalent | VESTA, INC. |
| K760125 | AIRWAY, ARGYLE NASOPHARYNGEAL | Jul 19, 1976 | Substantially Equivalent | SHERWOOD MEDICAL INDUSTRIES |
FEI Numbers
This FDA classification entry is associated with 127 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 127 registration numbers. Click on an entry to view related FDA registrations.