In-Line Oxygen Monitoring System
FDA 510(k) K821159 · G.D. Searle and Co.
510(k) numberK821159
Submission
- Device name
- In-Line Oxygen Monitoring System
- Applicant
- G.D. Searle and Co.
Walker, MI, US - Received
- April 22, 1982
- Decision date
- May 25, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DRY – Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4330
- Specialty
- Cardiovascular
Other 510(k)s with product code DRY
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|---|---|---|---|
| K234065 | CDI OneView Monitoring SystemDRY · Traditional | Terumo Cardiovascular Systems Corporation | 04/25/2024SE |
| K202154 | B-CaptaDRY · Traditional | Livanova Deutschland, GmbH | 04/01/2021SE |
| K202557 | Quantum Workstation 12 EliteDRY · Special | Spectrum Medical , Ltd. | 10/02/2020SE |
| K182110 | CDI Blood Parameter Monitoring System 550DRY · Traditional | Terumo Cardiovascular Systems Corporation | 11/02/2018SE |
| K181923 | Quantum Workstation 12.1DRY · Special | Spectrum Medical , Ltd. | 08/17/2018SE |
| K173591 | Quantum Diagnostic Module, Quantum Diagnostic Module - No GasDRY · Traditional | Spectrum Medical , Ltd. | 03/28/2018SE |
| K163657 | Quantum WorkstationDRY · Special | Spectrum Medical , Ltd. | 01/18/2017SE |
| K133157 | Tri-Optic Measurement Cell; with Balance Biosurface, with Carmeda Bioactive Surface…DRY · Traditional | Medtronic, Inc. | 10/23/2014SE |
| K133658 | Cdi Blood Parameter Monitoring System 500DRY · Traditional | Terumo Cardiovascular Systems Corp. | 07/25/2014SE |
| K123039 | Cdi Blood Parameter Monitoring System 500DRY · Traditional | Terumo Cardiovascular Systems Corp. | 11/20/2012SE |
More from Terumo Cardiovascular Systems Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K811068 | Bypass CoilKPY · Traditional | 05/27/1981SE |
| K811071 | Venous Oxygen ProbeCCE · Traditional | 05/05/1981SE |
| K803238 | Intravascular CatheterFOZ · Traditional | 04/23/1981SE |
| K810630 | Silicone Elastomer Coated Latex FoleyKOD · Traditional | 03/31/1981SE |
| K810131 | Administration SetFPD · Traditional | 02/26/1981SE |
| K802485 | Searle Vascular LoopsKDC · Traditional | 02/12/1981SE |
| K801805 | Metronidazole DiscsJWY · Traditional | 02/10/1981SE |
| K810112 | SWR Disposable Prep RazorKDC · Traditional | 02/04/1981SE |
| K802280 | White Knight Drape SealKKX · Traditional | 10/10/1980SE |
| K802213 | White Knight Bovie Cord/Suction TubeKKX · Traditional | 10/10/1980SE |
Questions and answers
When was In-Line Oxygen Monitoring System cleared by the FDA?
In-Line Oxygen Monitoring System (K821159) received a 510(k) decision of Substantially Equivalent on May 25, 1982, 33 days after the submission was received.
What is the product code of K821159?
The FDA product code is DRY – Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4330.