Flexwarmer, Models KZ-1 and KZ-2
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K062644 FDA 510(k)
- FDA Product Code
- LGZ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 880.5725 FDA 510(k)
- Regulation Number
- 880.5725 FDA 510(k)
- Advisory Committee
- General Hospital FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Flexwarmer, Models KZ-1 and KZ-2, is a Thermal Infusion Fluid Warmer designed to provide external heat to plastic tubing in administration sets. It is intended for intermittent use and low-flow applications, maintaining fluid temperatures within a controlled range to enhance patient comfort and safety during infusion therapy.
These devices are portable, single-use dry warmers with two channel sizes—4mm and 5mm—suitable for administration sets. Supplied sterile, they are classified as Class II devices under FDA regulations (21 CFR 880.5725) and were granted FDA 510(k) clearance as substantially equivalent to predicate devices. Storage and handling must comply with sterile medical device protocols.
Frequently asked questions
What are the primary use cases for the Flexwarmer, and how does it differ from continuous-flow warmers?
The Flexwarmer (Models KZ-1 and KZ-2) is designed for intermittent use and low-flow applications, ideal for situations where fluid warming is needed briefly or at reduced rates, such as during peripheral IV infusions or short-term therapies. Unlike continuous-flow warmers, it is not intended for high-volume or prolonged infusions. Its portable, dry-heat design gently warms plastic tubing (4mm or 5mm channels) to maintain fluid temperature, enhancing patient comfort without requiring constant fluid flow through the device.
Are the Flexwarmer models KZ-1 and KZ-2 reusable, or are they single-use devices?
The Flexwarmer is explicitly labeled as a single-use device. After one use, it should be discarded to maintain sterility and compliance with sterile medical device protocols. This design ensures patient safety and prevents cross-contamination between uses.
What tubing sizes does the Flexwarmer accommodate, and how does this affect compatibility with administration sets?
The Flexwarmer is available in two channel sizes: 4mm and 5mm, which correspond to common tubing diameters in administration sets. This makes it compatible with standard IV tubing used in general hospital settings for fluid warming during infusion therapy. The device’s design ensures a snug fit to maximize heat transfer while minimizing leakage.
How should the Flexwarmer be stored to preserve sterility and functionality before use?
Since the Flexwarmer is supplied sterile, it must be stored in its original packaging until ready for use. Storage should follow standard sterile medical device protocols—typically in a clean, dry environment away from direct sunlight or extreme temperatures. Avoid exposing it to moisture or contaminants, as this could compromise sterility or performance.
What regulatory pathway was followed for FDA clearance of the Flexwarmer, and what does this mean for clinicians?
The Flexwarmer received FDA 510(k) clearance under the Traditional review pathway, with a decision code of *SESE* (Substantially Equivalent to a predicate device). This classification means it was determined to have the same intended use and technological characteristics as an existing approved device, ensuring it meets FDA safety and effectiveness standards for thermal infusion fluid warmers. Clinicians can rely on its compliance with FDA regulations for Class II devices (21 CFR 880.5725).
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: FLEXWARMER, MODELS KZ-1 AND KZ-2 - fda.innolitics.com, Flexwarmer, Models Kz-1 And Kz-2 510 (k) FDA Premarket Notification ..., fda.innolitics.com, MERLYN ASSOCIATES, INC. FDA Filings - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K062644 | Class II | Active |
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Manufacturer
- Manufacturer
- Merlyn Associates, Inc.
Sources (1)
- FDA 510(k) K062644 24 fields · synced Sep 19, 2026