FDA product code BTQ: Airway, Nasopharyngeal
BTQ is the FDA product code for airway, nasopharyngeal. It is a Class I device, regulated under 21 CFR 868.5100 and reviewed by the Anesthesiology panel. FDA has cleared 19 510(k) submissions under BTQ, from 15 different applicants. The average 510(k) review took 78 days (median 32). FDA has posted 2 recalls for BTQ devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Airway, Nasopharyngeal |
| Device class | Class I |
| Regulation | 21 CFR 868.5100 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every BTQ clearance
Top BTQ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Vesta, Inc. | 3 | 1983-12-27 |
| Polamedco, Inc. | 2 | 1990-04-19 |
| Inmed Corp. | 2 | 1985-08-06 |
| Ad-Tech Medical Instrument Corp | 1 | 1995-09-19 |
| Coast Medical Corp. | 1 | 1992-06-11 |
10 more applicants have BTQ clearances. See the full list in Caduvo.
Most recent BTQ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K940320 | Ad-Tech Medical Instrument Corp | AD-TECH'S RAAB INFANT NASOPHARYNGEAL PRONGS | 1995-09-19 | 603 |
| K921353 | Coast Medical Corp. | NASOPHARYNGEAL AIRWAY | 1992-06-11 | 84 |
| K911784 | North American Sterilization & Packaging Co. | NORTEC ROBERTAZZI NASOPHARYNGEAL AIRWAY | 1991-09-23 | 154 |
| K903618 | Eastmed Enterprises, Inc. | ROBERTAZZI NASOPHARYNGEAL AIRWAY | 1991-01-08 | 154 |
| K900456 | Polamedco, Inc. | POLAMEDCO NASOPAHARYNGEAL AIRWAY | 1990-04-19 | 79 |
Recalls for BTQ devices
2 product recalls in 2 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2024-07-18.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2024 | 1 |
Frequently asked questions
What is FDA product code BTQ?
BTQ is the FDA product code for airway, nasopharyngeal. It is a Class I device, regulated under 21 CFR 868.5100 and reviewed by the Anesthesiology panel.
What device class is BTQ?
Class I, regulation 21 CFR 868.5100. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code BTQ?
Across 19 cleared submissions the average was 78 days from receipt to decision (median 32).
Which companies have the most BTQ clearances?
Vesta, Inc. (3); Polamedco, Inc. (2); Inmed Corp. (2); Ad-Tech Medical Instrument Corp (1); Coast Medical Corp. (1).
Have BTQ devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2024-07-18.
Next steps
- Run an FDA pathway report with predicate devices for product code BTQ
- Run a recall and safety report across every BTQ manufacturer
- Watch product code BTQ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
All Anesthesiology product codes · FDA product code lookup · 510(k) database search · 510(k) review times