510(k) · Cleared

Cleared

Cardis

K023015510(k) TraditionalCleared Sep 25, 200215-day reviewClass II21 CFR 870.1425

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Schwarzer GmbH · DQK Computer, Diagnostic, Programmable

Cleared on Sep 25, 2002 after a 15-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below).

Decided: Sep 25, 2002
Review: 15 days
Class: Class II
Product code: DQK
Recalls: None
Predicates: 1

The summary cites one number, which could not be confirmed as its predicate (see the table below).

FIG. 1 — Lineage of K023015Source: FDA 510(k) database · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in DQK? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new DQK device

#1 K213682 HemoSphere Advanced Monitor, HemoSphere…score 26.6 · 28 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

Type	Number	Device	Applicant	Decided	Recalls
Kept off the family tree	K021137	FDA’s K021137 is Sanarus Centrica Core Tissue Biopsy System Our reading of the summary gave K021137, FDA’s number for Sanarus Centrica Core Tissue Biopsy System (Sanarus Medical, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “CATHCOR Desktop”. Kept off the family tree. Summary page 1 …lation Number 870.1425 Predicate Device Legally marketed device to which equivalence is being claimed: CATHCOR Desktop 510(k) Number KO021137 Applied Guidances - Diagnostic ECG Guidance (Including Non-Alarming ST Segment Measurement); - Guidance for the Content o…	Sanarus Medical, Inc.	2002	—

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

How does its category compare?

All DQK devices

DQK Computer, Diagnostic, Programmable: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DQK

23so far in 2026, the most since 2007

2007high 23 (2026) · low 4 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DQK

95in 2025

2007high 190 (2016) · low 64 (2010)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DQK

1in 2025

2007high 24 (2024) · low 0 (2016)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · DQK

433in 2025

2007high 557 (2024) · low 18 (2007)2025

MAUDE reports naming product code DQK, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	13	83	4	18
2008	4	70	1	34
2009	12	93	2	40
2010	9	64	3	49
2011	12	69	2	55
2012	7	74	3	129
2013	13	68	1	180
2014	9	90	4	115
2015	7	125	2	131
2016	15	190	0	340
2017	7	146	2	252
2018	14	150	6	261
2019	15	113	1	218
2020	16	123	1	215
2021	16	132	1	351
2022	19	136	2	319
2023	21	133	2	340
2024	13	100	24	557
2025	22	95	1	433
2026	23	151	2	—

What is it indicated for?

The Schwarzer cardis heart catheter measuring systems with hemodynamical evaluation software are indicated for the registration, display, real-time recording, printout and storage of biophysiological data. Hemodynamic signals as intracardiac pressure, and ECG signals are recorded and displayed and a number of hemodynamic calculations are performed based on the measured values of the input signals.

The Schwarzer cardis systems are intended for use in catheterization labs

The Schwarzer cardis systems are indicated for use with patients of all ages under direct supervision of a physician or other trained health care professionals.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K023015 · printed Nov 6, 2026

Cite this page

510(k) Report. “K023015: Cardis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023015

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Page last updated Nov 3, 2026