Sterile Nasopharyngeal Airway
FDA 510(k) K853162 · Inmed Corp.
510(k) numberK853162
Submission
- Device name
- Sterile Nasopharyngeal Airway
- Applicant
- Inmed Corp.
Norcross, GA, US - Received
- July 30, 1985
- Decision date
- August 6, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- BTQ – Airway, Nasopharyngeal
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 868.5100
- Specialty
- Anesthesiology
Other 510(k)s with product code BTQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K940320 | Ad-Tech's Raab Infant Nasopharyngeal ProngsBTQ · Traditional | Ad-Tech Medical Instrument Corp | 09/19/1995SE |
| K921353 | Nasopharyngeal AirwayBTQ · Traditional | Coast Medical Corp. | 06/11/1992SE |
| K911784 | Nortec Robertazzi Nasopharyngeal AirwayBTQ · Traditional | North American Sterilization & Packaging Co. | 09/23/1991SE |
| K903618 | Robertazzi Nasopharyngeal AirwayBTQ · Traditional | Eastmed Enterprises, Inc. | 01/08/1991SE |
| K900456 | Polamedco Nasopaharyngeal AirwayBTQ · Traditional | Polamedco, Inc. | 04/19/1990SE |
| K901279 | Chatham Industries Nasopharyngeal AirwayBTQ · Traditional | Chatham Industries | 03/28/1990SE |
| K883668 | Sunderland Nasal TubeBTQ · Traditional | Exmoor Plastics , Ltd. | 11/21/1988SE |
| K873949 | Rorertazzi Nasopharyngeal AirwayBTQ · Traditional | Penn Medical Devices, Inc. | 10/20/1987SE |
| K871673 | Nasopharyngeal AirwayBTQ · Traditional | Harding Industries, Inc. | 06/15/1987SE |
| K850644 | Nasopharyngeal Airway-RobertazziBTQ · Traditional | Dryden Corp. | 03/21/1985SE |
More from Dryden Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K862672 | Esophageal Stethoscope with ThermistorBZT · Traditional | 10/27/1986SE |
| K850335 | Ureteroscopy CatheterKOD · Traditional | 03/12/1985SE |
| K850248 | Disposable Guedel AirwayCAE · Traditional | 03/12/1985SE |
| K850152 | Preconnected Urethral Catheter Tray · Traditional | 03/12/1985SE |
| K844801 | Ultra External CatheterKNX · Traditional | 01/15/1985SE |
| K842301 | Disposable Latex BandageKGX · Traditional | 11/05/1984SE |
| K842866 | Urethral Catheterization TrayKOD · Traditional | 09/10/1984SE |
| K841040 | Fox Post Nasal Balloon CatheterEMX · Traditional | 08/17/1984SE |
| K842865 | Esophageal StethoscopeBZW · Traditional | 08/15/1984SE |
| K841037 | Penrose Drains · Traditional | 04/25/1984SE |
Questions and answers
When was Sterile Nasopharyngeal Airway cleared by the FDA?
Sterile Nasopharyngeal Airway (K853162) received a 510(k) decision of Substantially Equivalent on August 6, 1985, 7 days after the submission was received.
What is the product code of K853162?
The FDA product code is BTQ – Airway, Nasopharyngeal, a Class I (low risk) device regulated under 21 CFR 868.5100.