Who is the manufacturer of MEDCARE SUCTION CONNECTING TUBING?

Medcare Medical Group, Inc. filed the 510(k) submission for MEDCARE SUCTION CONNECTING TUBING (K961880).

What is the FDA product code for MEDCARE SUCTION CONNECTING TUBING?

GCX. It is classified under 21 CFR 880.6740 as a Class 2 device in the General Hospital panel.

What is the regulatory pathway for MEDCARE SUCTION CONNECTING TUBING?

510(k) clearance (submission type: Traditional).

What are the predicate devices for MEDCARE SUCTION CONNECTING TUBING?

Suction Connecting Tubing (Kendall Healthcare Products Company).

Who can help prepare an FDA 510(k) submission like MEDCARE SUCTION CONNECTING TUBING?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

MEDCARE SUCTION CONNECTING TUBING

K961880 · Medcare Medical Group, Inc. · GCX · Jul 19, 1996 · General Hospital

Device Facts

Record ID	K961880
Device Name	MEDCARE SUCTION CONNECTING TUBING
Applicant	Medcare Medical Group, Inc.
Product Code	GCX · General Hospital
Decision Date	Jul 19, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 880.6740
Device Class	Class 2

Intended Use

The MedCare Suction Connecting Tubing is a single use disposable device indicated for general suction procedures as a connecting conduit from a suction device (i.e. Yankauer suction device, suction catheter, etc.) to a suction collection canister (vacuum source).

Device Story

Single-use disposable PVC tubing; connects suction devices (Yankauer, catheters) to vacuum collection canisters. Features injection-molded tapered PVC connectors with internal ribs for secure fitment. Used in clinical settings to facilitate fluid/debris removal via suction. Passive conduit; no active processing or electronic components.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Materials: Polyvinyl chloride (PVC). Design: Extruded tubing with solvent-bonded injection-molded tapered connectors featuring internal ribs. Form factor: Flexible tubing. Energy source: None (passive).

Indications for Use

Indicated for general suction procedures requiring a connecting conduit between a suction device (e.g., Yankauer, catheter) and a vacuum collection canister.

Regulatory Classification

Identification

A vacuum-powered body fluid suction apparatus is a device used to aspirate, remove, or sample body fluids. The device is powered by an external source of vacuum. This generic type of device includes vacuum regulators, vacuum collection bottles, suction catheters and tips, connecting flexible aspirating tubes, rigid suction tips, specimen traps, noninvasive tubing, and suction regulators (with gauge).

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.

Predicate Devices

Suction Connecting Tubing (Kendall Healthcare Products Company)

Related Devices

K964127 — MEDI-VAC FLEXI-CLEAR SUCTION HANDLE · Allegiance Healthcare Corp. · Dec 31, 1996
K993062 — CHEST DRAINAGE TUBING · Olson Medical Sales, Inc. · Dec 10, 1999
K060277 — BOEHRINGER LABORATORIES SUCTION PUMP SYSTEM · Boehringer Laboratories · Mar 3, 2006
K982891 — CALIFORNIA MEDICAL LABORATORIES INC. STANDARD AND SMALL RIGID TIP SUCTION WANDS · California Medical Laboratories, Inc. · Sep 30, 1998
K020510 — SMOKE EVACUATION HOSES/TUBING · Dm Medical, Inc. · May 3, 2002

Submission Summary (Full Text)

{0} JUL 19 1996 K96/880 (1) **510(k) Summary:** This summary is submitted in conformance with the format described in the 21 CFR Part 807.92 interim rule dated April 28, 1992. (1) **Submitted By:** MedCare Medical Group, Inc. 234 Old Homestead Highway E. Swanzey, NH 03446 **Contact Person:** Craig J. Bell Director of Research and Development (603)352-3230 (2) **Name of Device:** Suction Connecting Tubing **Classification Name:** Class II device, reference 21 CFR, Part 880.6740 (3) **Identification of Predicate Devices:** Suction Connecting Tubing (a) Kendall Healthcare Products Company Mansfield, MA 02048 (4) **Description of Device Subject to Premarket Notification:** The MedCare Suction Connecting Tubing is a single use disposable device indicated for general suction procedures as a connecting conduit from a suction device (i.e. Yankauer suction device, suction catheter, etc.) to a suction collection canister (vacuum source). The Suction Connecting Tubing is constructed of polyvinyl chloride (PVC) plastic extruded tubing with injection molded tapered connectors solvent bonded to each end. The connectors and made of PVC and have tapered internal diameters with internal ribs Page 8 of 11 {1} (5) **Intended Use of the Device:** The MedCare Suction Connecting Tubing is a single use disposable device indicated for general suction procedures as a connecting conduit from a suction device (i.e. Yankauer suction device, suction catheter, etc.) to a suction collection canister (vacuum source). (6) **Technological Characteristics** The MedCare Suction Connecting Tubing is made of similar construction and similar design to the predicate device for, as the name suggests, providing a tubing connection from the suction canister to a suction device. The MedCare Suction Connecting Tubing is provided with tapered fittings to allow secure fitment to a variety of suction devices.