Transtracheal Augmented Ventilation Oxygen Concentrator Model Number Ttav 1000
FDA 510(k) K981078 · Transtracheal Systems
510(k) numberK981078
Submission
- Device name
- Transtracheal Augmented Ventilation Oxygen Concentrator Model Number Ttav 1000
- Applicant
- Transtracheal Systems
Boulder, CO, US - Received
- March 24, 1998
- Decision date
- July 23, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- CAW – Generator, Oxygen, Portable
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5440
- Specialty
- Anesthesiology
Other 510(k)s with product code CAW
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|---|---|---|---|
| K260171 | Portable Oxygen Concentrator (PO1 5B, PO1 6B)CAW · Traditional | BMC Medical Co., Ltd. | 08/14/2026SE |
| K252399 | Portable Oxygen ConcentratorCAW · Traditional | Honsun (Nantong) Co., Ltd. | 06/17/2026SE |
| K252965 | Oxygen Concentrator (OX-5A, OX-5C)CAW · Traditional | Oxytek Medical Technology Co., Ltd. | 05/29/2026SE |
| K252407 | OxyGo Portable Oxygen Concentrator (1400-7000)CAW · Traditional | Mv Life, LLC | 04/23/2026SE |
| K253549 | DeVilbiss 5 Liter Oxygen Concentrator (555)CAW · Traditional | Devilbiss Healthcare, LLC | 03/26/2026SE |
| K251534 | Oxygen Concentrator (J10A)CAW · Traditional | Foshan Kycare Medical Equipment Co., Ltd. | 12/29/2025SE |
| K252616 | Portable oxygen concentrator (JLO-190P)CAW · Traditional | Shenzhen Homed Medical Device Co., Ltd. | 12/22/2025SE |
| K251764 | Oxygen Concentrator-P2-O5ECAW · Traditional | Qingdao Kingon Medical Science and Technology… | 12/22/2025SE |
| K252268 | V series portable oxygen concentrator (V5, V5C, V6, V6C)CAW · Traditional | Shenzhen Harveymed Technology Co., Ltd. | 12/16/2025SE |
| K250805 | DeVilbiss PulmO2 10-Liter Oxygen Concentrator (1060AW)CAW · Traditional | Devilbiss Healthcare, LLC | 12/09/2025SE |
More from Devilbiss Healthcare, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K982943 | Transtracheal Demand Oxygen Controller Model DOC-3000NFB · Traditional | 07/12/1999SE |
| K981080 | Scoop 1BTO · Traditional | 06/17/1998SE |
| K962944 | Transtracheal Demand Oxygen Controller (DOC-2000)NFB · Traditional | 10/23/1996SE |
| K904749 | Transkinetics Rado Freq Multi-Lead Tele Syst 7200DRQ · Traditional | 03/01/1991SE |
| K904748 | Transkinetics Infrared Multi-Lead Tele Syst 7100DRG · Traditional | 03/01/1991SE |
| K902281 | Modified Scoop Transtracheal CathetersBTO · Traditional | 08/10/1990SE |
| K854252 | Transtracheal System-Scoop-Insertion Tray-CatheterBTO · Traditional | 02/03/1986SESD |
Questions and answers
When was Transtracheal Augmented Ventilation Oxygen Concentrator Model Number Ttav 1000 cleared by the FDA?
Transtracheal Augmented Ventilation Oxygen Concentrator Model Number Ttav 1000 (K981078) received a 510(k) decision of Substantially Equivalent on July 23, 1998, 121 days after the submission was received.
What is the product code of K981078?
The FDA product code is CAW – Generator, Oxygen, Portable, a Class II (moderate risk) device regulated under 21 CFR 868.5440.