Inspectra Tissue Spectrometer System (Inspectra), Model 325
FDA 510(k) K012759 · Hutchinson Technology, Inc.
510(k) numberK012759
Submission
- Device name
- Inspectra Tissue Spectrometer System (Inspectra), Model 325
- Applicant
- Hutchinson Technology, Inc.
Hutchinson, MN, US - Received
- August 17, 2001
- Decision date
- January 17, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MUD – Oximeter, Tissue Saturation
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2700
- Specialty
- Cardiovascular
Other 510(k)s with product code MUD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K254129 | Spectrum-2MUD · Traditional | Neko Health AB | 05/22/2026SE |
| K243324 | Masimo O3 Regional OximeterMUD · Traditional | Masimo Corporation | 07/17/2025SE |
| K250519 | Lap.Ox Laparoscopic Tissue OximeterMUD · Traditional | ViOptix, Inc. | 06/26/2025SE |
| K240596 | Cerebral Autoregulation Index (CAI) AlgorithmMUD · Traditional | Edwards Lifesciences | 10/16/2024SE |
| K241393 | ODI-TechMUD · Traditional | Odi Medical AS | 08/30/2024SE |
| K240601 | SnapshotNIR model KD205MUD · Traditional | Kent Imaging, Inc. | 04/02/2024SE |
| K232385 | OxiplexTS200MUD · Traditional | Iss Medical, Inc. | 03/01/2024SE |
| K233488 | Intra.Ox 2.0 Handheld Tissue OximeterMUD · Traditional | Vioptix, Inc. | 02/28/2024SE |
| K230612 | Edwards Algorithm for Measurement of Blood HemoglobinMUD · Traditional | Edwards Lifesciences, LLC | 11/17/2023SE |
| K223651 | Cerebral Adaptive Index (CAI) AlgorithmMUD · Traditional | Edwards Lifesciences, LLC | 05/26/2023SE |
More from Edwards Lifesciences, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K103613 | Inpectra STO2 Spot CheckMUD · Traditional | 03/02/2011SE |
| K100915 | Inspectra STO2 Tissue Oxygenation Monitor, Model 650MUD · Special | 04/30/2010SE |
| K061619 | Inspectra STO2 Tissue Oxygenation MonitorMUD · Traditional | 07/12/2006SE |
| K053618 | Inspectra Tissue Spectrometer System, Model 325MUD · Traditional | 02/08/2006SE |
| K042020 | Spectra Tissue Spectrometer System (Inspectra)MUD · Traditional | 09/15/2004SE |
| K023938 | Modification to Inspectra Tissue Spectrometer System, Model 325MUD · Special | 12/13/2002SE |
| K963903 | Biospectrometer-Nb Oximeter IiiiMUD · Traditional | 01/27/1998SE |
Questions and answers
When was Inspectra Tissue Spectrometer System (Inspectra), Model 325 cleared by the FDA?
Inspectra Tissue Spectrometer System (Inspectra), Model 325 (K012759) received a 510(k) decision of Substantially Equivalent on January 17, 2002, 153 days after the submission was received.
What is the product code of K012759?
The FDA product code is MUD – Oximeter, Tissue Saturation, a Class II (moderate risk) device regulated under 21 CFR 870.2700.