Iisis, Version 1.0
FDA 510(k) K052244 · Innovision Medical Technologies, LLC
510(k) numberK052244
Submission
- Device name
- Iisis, Version 1.0
- Applicant
- Innovision Medical Technologies, LLC
Linthicum, MD, US - Received
- August 17, 2005
- Decision date
- October 13, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MOD – Accessory To Continuous Ventilator (Respirator)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5895
- Specialty
- Anesthesiology
Other 510(k)s with product code MOD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261360 | EasyCare Tx 2MOD · Traditional | Resmed Corp | 08/27/2026SE |
| K253807 | Valence InVent Xtend (CVG-4101-VXA)MOD · Traditional | Convergence Medical Sciences , Ltd. | 08/20/2026SE |
| K260051 | CorVision® (91-205-Z0014)MOD · Traditional | CorVent® Medical, Inc. | 05/12/2026SE |
| K242485 | EveryWareMOD · Traditional | Breas Medical AB | 05/20/2025SE |
| K161411 | Care Cycle Connect ApplicationMOD · Traditional | Respironics, Inc. | 02/17/2017SE |
| K091461 | Bernoulli Management System, Oxinet III and Lifegard VueMOD · Traditional | Cardiopulmonary Corp. | 08/14/2009SE |
| K052751 | Ventlink SystemMOD · Traditional | Mediserve Information Systems, Inc. | 12/23/2005SE |
| K040712 | Air Safety Hepa, Model 3500MOD · Traditional | Air Safety, Ltd. | 06/03/2004SE |
| K022062 | Impact, Universal Single-Limb, Ventilator Circuit, Model 820-0099-00MOD · Abbreviated | Impact Instrumentation, Inc. | 05/06/2003SE |
| K010401 | Tri-Plex AdapterMOD · Traditional | The Medical Device Group, Inc. | 10/30/2002SE |
Questions and answers
When was Iisis, Version 1.0 cleared by the FDA?
Iisis, Version 1.0 (K052244) received a 510(k) decision of Substantially Equivalent on October 13, 2005, 57 days after the submission was received.
What is the product code of K052244?
The FDA product code is MOD – Accessory To Continuous Ventilator (Respirator), a Class II (moderate risk) device regulated under 21 CFR 868.5895.