Fast-Pass Ace Models 1212T/1222T/1216T/1226T

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

510(k) Number

K900550 ↗

FDA Product Code

DTB

Models / Variants

1212T

1222T

1216T

1226T

Device Class

Class III

Regulation

21 CFR Part 870.3680

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Vascutek Vascular Prothesis VP1200K/50K

  Class II

  FDA 510(k) K830016 Active Cleared 21 Dec 1983

• Vivalith 5 - MDL-201A & TDL-201A

  Class III

  FDA 510(k) K801763 Active Cleared 27 Aug 1980

• Cardiovascular Permanent Pacemaker Electrode

  Class III

  FDA 510(k) K891905 Active Cleared 5 Jun 1989

• Pacemaker Connector Plug

  Class II

  FDA 510(k) K821548 Active Cleared 2 Jun 1982

• Personal Medication Infuser

  Class II

  FDA 510(k) K830570 Active Cleared 24 Mar 1983

• Pacemaker Unipolar Adapter

  Class II

  FDA 510(k) K821547 Active Cleared 2 Jun 1982

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• Are these electrodes reusable or intended for single-use, and how should they be handled after implantation?

  These electrodes are explicitly designed for single-use only and are supplied sterile. After implantation, they should be discarded according to standard medical device disposal protocols to ensure patient safety and prevent cross-contamination. The sterile packaging ensures they remain uncontaminated until use in a controlled clinical setting.

• What distinguishes the different model numbers (1212T, 1222T, 1216T, 1226T) in terms of their intended use?

  Each model number corresponds to a specific electrode configuration tailored for different pacing needs. While the exact differences (e.g., lead length, tip design, or pacing capabilities) are not detailed in the provided data, the variations allow clinicians to select the appropriate model based on the patient’s anatomy and pacing requirements. Consult the manufacturer’s technical documentation for precise specifications.

• How are these electrodes regulated in the U.S., and what pathway was used for FDA clearance?

  These electrodes are classified as Class III medical devices under FDA product code DTB and were cleared via a traditional 510(k) pathway (K900550). The clearance was granted under 21 CFR 870.3680, with a decision of *Substantially Equivalent* (SESE) by the FDA’s Cardiovascular (CV) Advisory Committee. This pathway ensures rigorous review for devices intended to regulate heart rhythm.

• What storage conditions should be followed for these sterile electrodes before use?

  While specific storage conditions aren’t detailed in the data, sterile medical devices like these typically require protection from moisture, extreme temperatures, and physical damage. They should be stored in their original, unopened packaging in a clean, dry environment as recommended by the manufacturer. Always verify the expiration date and integrity of the packaging before use.