Question 1

What types of medical devices does Aplicare, Inc. manufacture?

Accepted Answer

Aplicare, Inc. specializes in topical medical devices primarily used for preparation, lubrication, and skin protection during medical procedures. Their portfolio includes general-body orifice lubricants like lubricating jelly, sterile water for suction catheters, skin protectant prep pads and swabsticks, alcohol-based prep solutions, and saline for catheter lubrication. These products are designed to support safe and effective medical interventions by reducing irritation, aiding insertion, and preparing skin for procedures.

Question 2

Where is Aplicare, Inc. based, and how does that affect its regulatory compliance?

Accepted Answer

Aplicare, Inc. is based in the United States, which means its devices are subject to U.S. Food and Drug Administration (FDA) regulations. Since the company’s products fall under FDA classifications—such as Class I, Class II, and Unclassified (U) devices—they must comply with U.S. medical device laws. This includes registration in the FDA’s 510(k) and Unique Device Identifier (UDI) systems, ensuring traceability and adherence to safety standards for distribution in the U.S. market.

Question 3

Which regulatory registries list Aplicare’s devices, and why are these important?

Accepted Answer

Aplicare’s devices are listed in the FDA’s 510(k) and Unique Device Identifier (UDI) registries. The 510(k) process demonstrates that a device is substantially equivalent to a legally marketed predicate device, while the UDI system ensures each product can be uniquely identified for tracking, safety monitoring, and compliance purposes. These registries help healthcare providers, regulators, and supply chains verify the device’s authorized status and trace its distribution history.

Question 4

How are Aplicare’s devices classified by the FDA, and what does that classification mean?

Accepted Answer

Aplicare’s devices are classified under FDA categories including Class I (low-risk, generally exempt from premarket notification), Class II (moderate-risk requiring special controls), and Unclassified (U) devices. Classification determines the regulatory pathway: Class I devices often require less scrutiny, while Class II devices may need additional testing or documentation to prove safety and effectiveness. The Unclassified designation indicates these devices are not yet assigned a specific risk class but are still subject to FDA oversight to ensure compliance with medical device regulations.

Device	Model / Reference	Registries	Class	Status
Aplicare Lubricating Jelly	82-281	FDA UDI	Class II	Active
Aplicare Lubricating Jelly	82-280	FDA UDI	Class II	Active
Aplicare Sterile Water - For Suction Catheter Only	K873563	FDA 510(k)	Class II	Active
Aplicare Skin Protectant Prep Pad	K861557	FDA 510(k)	Class I	Active
Aplicare One Compund Benzion Tincture Swabstick	K923299	FDA 510(k)	Class I	Active
Aplicare Skin Protectant Swabstick	K861558	FDA 510(k)	Class I	Active
Acetone Alcohol Prep Pad	K833185	FDA 510(k)	U	Active
Aplicare One Acetone Alcohol Swabstick	K833183	FDA 510(k)	U	Active
Aplicare Three Alcohol Swabsticks	K833184	FDA 510(k)	U	Active
Aplicare Alcohol Prep Pad	K833182	FDA 510(k)	U	Active
Sterile Saline - For Suction Catheter Lubrication	K895039	FDA 510(k)	Class II	Active

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