Vti Oxygen Analyzer
FDA 510(k) K922738 · Vascular Technology Incorporated
510(k) numberK922738
Submission
- Device name
- Vti Oxygen Analyzer
- Applicant
- Vascular Technology Incorporated
Chelmsford, MA, US - Received
- June 8, 1992
- Decision date
- January 27, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- CCL – Analyzer, Gas, Oxygen, Gaseous-Phase
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.1720
- Specialty
- Anesthesiology
Other 510(k)s with product code CCL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261389 | PRO2 Elite Plus Oxygen Analyzer (PRO2PLUS-1)CCL · Traditional | Salter Labs | 07/30/2026SE |
| K251245 | OxyMinder Pro (10310)CCL · Traditional | Bio-Med Device, Inc. | 08/11/2025SE |
| K250002 | Smart Check O2 (MA0236)CCL · Traditional | Life Spark Medical, LLC | 04/24/2025SE |
| K221734 | Maxtec MaxO2 ME+pCCL · Traditional | Maxtec, LLC | 04/01/2023SE |
| K213933 | Percent Oxygen SensorsCCL · Traditional | Careox, LLC | 08/19/2022SE |
| K213948 | OxyMinderCCL · Traditional | Bio-Med Devices, Inc. | 03/17/2022SE |
| K173807 | Accu O2 Oxygen AnalyzerCCL · Abbreviated | Precision Medical, Inc. | 05/02/2018SE |
| K153659 | MaxO2MECCL · Traditional | Maxtec, LLC | 06/10/2016SE |
| K123195 | Carescape Respiratory Modules, E-Sco, E-Scov, E-Scaiov and AccessoriesCCL · Traditional | GE Healthcare Finland Oy | 02/28/2013SE |
| K122290 | Envitec Mysign O Oxygen Measuring DeviceCCL · Traditional | Envitec-Wismar GmbH | 01/23/2013SE |
More from Envitec-Wismar GmbH
| 510(k) | Device | Decision |
|---|---|---|
| K082870 | Vti Intraoperative Doppler SystemsDPW · Special | 10/28/2008SE |
| K031091 | Vti 20 MHZ Gated DopplerDPW · Traditional | 04/23/2003SE |
| K002990 | Vti Adult Disposable Skull Pin, Model 22000; Vti Skull Screw, Model 22001HBL · Traditional | 11/06/2000SE |
| K944764 | Vti Disposable Pressure Display SetDXS · Traditional | 12/27/1994SE |
| K890058 | Vascular Technology Uniox Oxygen AlarmCCL · Traditional | 11/21/1989SE |
| K883960 | Giphy MonitorFFT · Traditional | 10/04/1989SE |
| K864583 | Cardiac Performance MonitorDQK · Traditional | 05/11/1987SE |
| K862114 | Khuri Regional Tissue PH MonitorCBZ · Traditional | 06/25/1986SE |
| K862113 | No. 100352 Galvanic Oxygen SensorCCL · Traditional | 06/19/1986SE |
| K852275 | Vascular Tech # 100123 Polarographic Oxgyen SensorCCL · Traditional | 06/20/1985SE |
Questions and answers
When was Vti Oxygen Analyzer cleared by the FDA?
Vti Oxygen Analyzer (K922738) received a 510(k) decision of Substantially Equivalent on January 27, 1993, 233 days after the submission was received.
What is the product code of K922738?
The FDA product code is CCL – Analyzer, Gas, Oxygen, Gaseous-Phase, a Class II (moderate risk) device regulated under 21 CFR 868.1720.