Tube-Title
FDA 510(k) K833361 · Sontek Industries, Inc.
510(k) numberK833361
Submission
- Device name
- Tube-Title
- Applicant
- Sontek Industries, Inc.
Mchenry, IL, US - Received
- September 27, 1983
- Decision date
- November 3, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JAY – Support, Breathing Tube
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 868.5280
- Specialty
- Anesthesiology
Other 510(k)s with product code JAY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K944988 | Custom Medical Suspension StrapJAY · Traditional | Custom Medical Specialties, Inc. | 01/27/1995SE |
| K873491 | Block, Bite, IntubationJAY · Traditional | B&B Medical Technologies, Inc. | 10/20/1987SE |
| K860583 | Dale Head Band Anesthesia Circuit Tube Holder 1315JAY · Traditional | Dale Medical Products, Inc. | 02/21/1986SE |
| K850924 | Jee Frame (Ventilator Circuit Support)JAY · Traditional | Vulcan Laboratories, Inc. | 07/19/1985SE |
| K850309 | Comfit Plus Endotracheal Tube Holder & Bite BlockJAY · Traditional | Ackrad Laboratories | 02/14/1985SE |
| K840844 | Endo-SecureJAY · Traditional | Exidyne, Inc. | 03/16/1984SE |
| K834265 | Trach MateJAY · Traditional | Tempe Biomedical, Inc. | 01/04/1984SE |
| K834089 | ComfitJAY · Traditional | Ackrad Laboratories | 12/29/1983SE |
| K833374 | Bite-BlockJAY · Traditional | Sontek Industries, Inc. | 11/03/1983SE |
| K833332 | Schultz EndholdJAY · Traditional | Polyclinic Medical Center | 10/31/1983SE |
More from Polyclinic Medical Center
| 510(k) | Device | Decision |
|---|---|---|
| K833374 | Bite-BlockJAY · Traditional | 11/03/1983SE |
| K833373 | Bodia Bronch-Saf Double SwivelBZA · Traditional | 11/03/1983SE |
| K833372 | Bodia Trach-Saf Double SwivelBZA · Traditional | 11/03/1983SE |
| K813324 | Bodai Swivel YBSY · Traditional | 12/29/1981SE |
| K812720 | Bodai Patient CommunicatorILQ · Traditional | 11/05/1981SE |
| K811241 | Bodai Suction -Safe 4BSY · Traditional | 05/27/1981SE |
Questions and answers
When was Tube-Title cleared by the FDA?
Tube-Title (K833361) received a 510(k) decision of Substantially Equivalent on November 3, 1983, 37 days after the submission was received.
What is the product code of K833361?
The FDA product code is JAY – Support, Breathing Tube, a Class I (low risk) device regulated under 21 CFR 868.5280.