Modification of Crit-Line Monitor III (CLM III)
FDA 510(k) K982412 · In-Line Diagnostics Corp.
510(k) numberK982412
Submission
- Device name
- Modification of Crit-Line Monitor III (CLM III)
- Applicant
- In-Line Diagnostics Corp.
Farmington, UT, US - Received
- July 13, 1998
- Decision date
- October 9, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MQS – System, Hemodialysis, Access Recirculation Monitoring
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5820
- Specialty
- Gastroenterology, Urology
- Life-sustaining
- Yes
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| K232283 | PhySoftAMS®MQS · Traditional | Physician Software Systems, LLC | 12/14/2023SE |
| K180410 | Dosis SAMMQS · Traditional | Dosis, Inc. | 01/16/2019SE |
| K130579 | Physoft AmsMQS · Traditional | Physicians Software Systems, LLC | 12/19/2013SE |
| K042566 | Vasc-AlertMQS · Traditional | Vasc-Alert, Inc. | 11/08/2004SE |
| K022963 | Transonic Syringe Warmer, Model SYR-1000MQS · Traditional | Transonic Systems, Inc. | 12/04/2002SE |
| K021571 | Transonic Flow-Qc Set Model ADT1010MQS · Traditional | Transonic Systems, Inc. | 08/12/2002SE |
| K001763 | Crit-Line Monitor III (CLM III)MQS · Traditional | In-Line Diagnostics Corp. | 12/20/2000SE |
| K993587 | HP M2376A Device Link SystemMQS · Traditional | Hewlett-Packard Co. | 01/20/2000SE |
| K992227 | Crit-Line Monitor III (CLM III)MQS · Special | In-Line Diagnostics Corp. | 07/30/1999SE |
| K984194 | HP M2376A Device Link SystemMQS · Traditional | Hewlett-Packard Co. | 04/30/1999SE |
More from Hewlett-Packard Co.
| 510(k) | Device | Decision |
|---|---|---|
| K001763 | Crit-Line Monitor III (CLM III)MQS · Traditional | 12/20/2000SE |
| K992227 | Crit-Line Monitor III (CLM III)MQS · Special | 07/30/1999SE |
| K983551 | Crit-Scan II MonitorGKF · Traditional | 05/27/1999SE |
| K972470 | Crit-Line Monitor (Clmiii)MQS · Traditional | 12/11/1997SE |
| K953875 | Crit-Line Hematocrit Alert (Modification)MQS · Traditional | 07/23/1996SE |
| K950942 | Crit-Line Hematocrit AlertJPI · Traditional | 03/14/1995SE |
| K935958 | Crit-Line Blood Chamber with E-BeamKOC · Traditional | 01/19/1995SE |
Questions and answers
When was Modification of Crit-Line Monitor III (CLM III) cleared by the FDA?
Modification of Crit-Line Monitor III (CLM III) (K982412) received a 510(k) decision of Substantially Equivalent on October 9, 1998, 88 days after the submission was received.
What is the product code of K982412?
The FDA product code is MQS – System, Hemodialysis, Access Recirculation Monitoring, a Class II (moderate risk) device regulated under 21 CFR 876.5820.