Comfort-Q Subcutaneous Injection Sets

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K946170 ↗

FDA Product Code

FOZ

Device Class

Class II

Regulation

21 CFR Part 880.5200

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

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See all devices from B. Braun of America, Inc. →

• Are these subcutaneous injection sets reusable, or are they meant for single-use only per patient?

  The Comfort-Q Subcutaneous Injection Sets are explicitly designed for single-use only per patient. The manufacturer and regulatory data emphasize they are sterile, disposable devices, meaning each set should be discarded after one use to maintain sterility and patient safety. Reuse is not recommended or supported by the device’s intended design.

• What types of fluids or medications can these injection sets deliver, and how do they ensure precise dosing?

  These sets are intended for subcutaneous infusion or injection of fluids, medications, or nutrients into the subcutaneous tissue layer. The design includes a needle and tubing assembly configured to deliver precise volumes, making them suitable for therapeutic or nutritional applications. While the exact types of fluids aren’t specified, the precision comes from the structured assembly rather than a specific measurement feature.

• How should I store these injection sets before use, and what should I look for to ensure they’re still safe to use?

  The Comfort-Q Subcutaneous Injection Sets are sterile and should be stored in their original packaging until use, following standard sterile supply protocols. Since they’re single-use, check for damage to the packaging, expiration dates (if applicable), or visible contamination before use. The manufacturer does not specify storage conditions beyond ensuring sterility, so avoid exposure to extreme temperatures or moisture.

• What regulatory pathway was followed for FDA clearance, and which advisory committee reviewed this device?

  The Comfort-Q Subcutaneous Injection Sets received FDA 510(k) clearance (K946170) under the Traditional review pathway, meaning the manufacturer demonstrated substantial equivalence to a predicate device. The General Hospital Advisory Committee (HO) reviewed this submission, which falls under the FDA product code FOZ (Hospitals, General and Plastic Surgery). No additional regulatory status (e.g., CE marking) is mentioned in the data.