Daily Cleaning Solution Kit 2118

by Medica Corp.

Daily Cleaning Solution Kit 2118 is a Class II device made by Medica Corp., cleared under FDA 510(k) K021515 on 16 Jul 2002 and listed in FDA GUDID since 4 Dec 2018 (UDI-DI 00386100002398), active as of 23 Oct 2026. One FDA recall is linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

This device is named in the recall

Documents

FDA submission, from GUDID

Trust

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00386100002398 UDI-DI	Date4 Dec 2018Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK021515	Date16 Jul 2002Decided	StatusActive

Official records

AccessGUDID record UDI-DI 00386100002398
FDA 510(k) database 510(k) number K021515

Across registries

2 registries list this device

FDA 510(k) K021515 decided 16 Jul 2002 Active
FDA GUDID UDI-DI 00386100002398 listed 4 Dec 2018 Listed

Recalls

1 recall · 1 ongoing · FDA

- Ongoing Z-1370-2026 FDA Class II initiated 31 Dec 2025
A systematic positive bias of up to 20% was identified across the reportable potassium range, resulting in false elevation results of patient samples when using Medica s capillary tubes.

Timeline

3 dated events

16 Jul 2002 Cleared FDA 510(k) K021515
4 Dec 2018 Listed FDA GUDID 00386100002398
31 Dec 2025 Recall initiated FDA recalls Z-1370-2026

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Daily Cleaning Solution Kit
Generic name: Wash/cleaning solution IVD, automated/semi-automated system
Model / Ref / Catalog: 2118

Primary DI / UDI-DI: 00386100002398
510(k) Number: K021515
FDA product code: CEM, JGS, JFP, GKF, CHL
GMDN term: Wash/cleaning solution IVD, automated/semi-automated system

Device class: Class II
Regulation number: 862.1600, 862.1665, 862.1145, 864.5600, 862.1120
GUDID distribution status: In Commercial Distribution

Similar devices in this category

Other devices filed under Wash/cleaning solution IVD, automated/semi-automated system.

Other devices from Medica Corp.

Reference Electrode

Class B
LUER LOCK Adaptor for pneumodissector C05-ADPT-PDH

Class I
Handle for pneumodissection Hook C05-H-PDH

Class II
Hook insert and tube for pneumodissection D=5, 0mm Lg=20cm, sterile single use C05-ID-CH-20-ST

Class II

See all devices from Medica Corp. →

Properties

Prescription use
Lot / batch number
Expiration date
Manufacturing date

Other properties (11, all answered No)