# Maxtec, LLC

- Location (FDA's records): Salt Lake City, UT
- FDA decisions: 10 (2004–2023): 10 510(k) clearances
- Names in FDA's records: Maxtec, LLC (6); Maxtec, Inc. (4)
- Product codes: CCL (5), BZR (3), CCK (2)
- Predicates its devices cite: 19 (4 its own); citations of its devices by later devices: 14 (4 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Mercury Medical: 3 (https://510kreport.com/company/mercury-medical)
- Precision Medical, Inc.: 2 (https://510kreport.com/company/precision-medical)
- Caradyne, Ltd.: 2 (https://510kreport.com/company/caradyne)
- Bird Products Corp.: 2 (https://510kreport.com/company/bird-products)
- Digiflo, Inc.: 1 (https://510kreport.com/company/digiflo)
- Invacare Corp.: 1 (https://510kreport.com/company/invacare)
- Medical Technology Specialists, Inc.: 1 (https://510kreport.com/company/medical-technology-specialists)
- Ceramatec, Inc.: 1 (https://510kreport.com/company/ceramatec)

## Firms that cite its devices most
- Envitec-Wismar GmbH: 2 (https://510kreport.com/company/envitec-wismar)
- Precision Medical, Inc.: 1 (https://510kreport.com/company/precision-medical)
- Fisher & Paykel Healthcare, Ltd.: 1 (https://510kreport.com/company/fisher-paykel-healthcare)
- Vapotherm, Inc.: 1 (https://510kreport.com/company/vapotherm)
- Bio-Med Devices, Inc.: 1 (https://510kreport.com/company/bio-med-devices)
- Bio-Med Device, Inc.: 1 (https://510kreport.com/company/bio-med-device)
- Life Spark Medical, LLC: 1 (https://510kreport.com/company/life-spark-medical)
- Affirm Medical Technologies II, LLC: 1 (https://510kreport.com/company/affirm-medical-technologies-ii)

## Its most-cited devices
- K040484: MAXO2+, Model a and AE (2004), cited by 3
- K153659: MaxO2ME (2016), cited by 2
- K112402: ULTRAMAXO2 Oxygen Analyer (2011), cited by 2
- K063488: MAXO2 CU (2007), cited by 2
- K161718: MaxBlend 2, MaxBlend Lite (2016), cited by 2
- K221734: Maxtec MaxO2 ME+p (2023), cited by 2

## Recent decisions
- K231895: Maxtec MaxBlend2+p (Dec 4, 2023)
- K221734: Maxtec MaxO2 ME+p (Apr 1, 2023)
- K182362: MaxCap Ped and MaxCap Neo (May 23, 2019)
- K161718: MaxBlend 2, MaxBlend Lite (Oct 27, 2016)
- K153659: MaxO2ME (Jun 10, 2016)
- K133540: Flocap (Mar 28, 2014)
- K113232: Maxmixing Block (Mar 1, 2012)
- K112402: ULTRAMAXO2 Oxygen Analyer (Dec 14, 2011)

Source page: https://510kreport.com/company/maxtec