510(k) Report

510(k) · Cleared

Cleared

Cardio ID+(RZ153+)

K022540510(k) TraditionalCleared Oct 24, 200284-day reviewClass II21 CFR 870.2800

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

Rozinn Electronics, Inc. · DSH Recorder, Magnetic Tape, Medical

Cleared on Oct 24, 2002 as substantially equivalent to K001288 (North East Monitoring, Inc., 2000) after an 84-day review. Its family tree reaches back 1 generation to 2000. 59 later devices descend from it.

Decided
Oct 24, 2002
Review
84 days
Class
Class II
Product code
DSH
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K001288 (2000). 59 later devices descend from it, 6 citing it directly.

Descendants, by year cleared 2010: 2 descendants cleared2003: 1 descendant cleared2013: 1 descendant cleared2005: 3 descendants cleared2014: 4 descendants cleared2007: 2 descendants cleared2019: 4 descendants cleared2011: 2 descendants cleared2018: 1 descendant cleared2016: 5 descendants cleared2015: 4 descendants cleared2008: 1 descendant cleared2020: 4 descendants cleared2012: 1 descendant cleared2017: 6 descendants cleared2026: 4 descendants cleared2022: 2 descendants cleared2021: 4 descendants cleared2023: 6 descendants cleared2025: 1 descendant cleared2024: 1 descendant clearedK001288 · DR180-II · North East Monitoring, Inc. · 2000200020052010201520202025
Descendants, by generation 1 generation forward: 6 descendants2 generations forward: 7 descendants3 generations forward: 10 descendants4 generations forward: 11 descendants5 generations forward: 13 descendants6 generations forward: 6 descendants7 generations forward: 3 descendants8 generations forward: 1 descendant9 generations forward: 1 descendant10 generations forward: 1 descendant K001288 · DR180-II · North East Monitoring, Inc. · 20000+5+10
  1. Root · 1 generation backK001288 DR180-IINorth East Monitoring, Inc. · 2000
  2. This deviceK022540 Cardio ID+(RZ153+)Rozinn Electronics, Inc. · 2002
  3. Descendant · cites it directly · 56 of its ownK032466 SpiderviewEla Medical, Inc. · 2003
  4. Descendant · cites it directly · 46 of its ownK042108 Vista PlusNovacor · 2005
  5. Descendant · 2 generations on · 40 of its ownK071641 Reveal XT; Insertable Cardiac Monitor (Model 9529), Patient…Medtronic, Inc. · 2007
  6. Descendant · 2 generations on · 30 of its ownK071655 Reveal DX Insertable Cardiac Monitor, Reveal Patient Assistant…Medtronic, Inc. · 2007
  7. Descendant · 3 generations on · 28 of its ownK082475 Reveal XT Insertable Cardiac Monitor, Model 9529, Revel DX…Medtronic, Inc. · 2008

Showing 5 of 59 descendants. See all descendants

Descendants cleared per year

2003: 12005: 32007: 22008: 12010: 22011: 22012: 12013: 12014: 42015: 42016: 52017: 62018: 12019: 42020: 42021: 42022: 22023: 62024: 12025: 12026: 4
2003high 6 (2017) · low 0 (2004)2026

Most influential descendants

Showing 5 of 59 · See all
  • K032466SpiderviewEla Medical, Inc. · 2003 · cites it directly56descendants
  • K042108Vista PlusNovacor · 2005 · cites it directly46descendants
  • K071641Reveal XT; Insertable Cardiac Monitor (Model 9529), Patient Assistant (Model 9539)Medtronic, Inc. · 2007 · 2 generations on40descendants
  • K071655Reveal DX Insertable Cardiac Monitor, Reveal Patient Assistant, Model (S) 9528,9538Medtronic, Inc. · 2007 · 2 generations on30descendants
  • K082475Reveal XT Insertable Cardiac Monitor, Model 9529, Revel DX Insertable Cardiac Monitor…Medtronic, Inc. · 2008 · 3 generations on28descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K001288DR180-IINorth East Monitoring, Inc.2000—
0 (this device)K022540Cardio ID+(RZ153+)Rozinn Electronics, Inc.2002—
+1K032466SpiderviewEla Medical, Inc.2003—
+1K042108Vista PlusNovacor2005—
+2K071641Reveal XT; Insertable Cardiac Monitor (Model 9529), Patient Assistant (Model…Medtronic, Inc.2007—
+2K071655Reveal DX Insertable Cardiac Monitor, Reveal Patient Assistant, Model (S)…Medtronic, Inc.2007—
+3K082475Reveal XT Insertable Cardiac Monitor, Model 9529, Revel DX Insertable Cardiac…Medtronic, Inc.2008—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
200530
200720
200810
201020
201120
201210
201310
201440
201540
201650
201760
201810
201940
202040
202140
202220
202360
202410
202510
202640
FIG. 1 — Lineage of K022540, 2000–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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 DSH? 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 DSH device

  1. #1 K260157 LifeLens Physiological Monitorscore 17.9 · 22 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

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.

TypeNumberDeviceApplicantDecidedRecalls
*K001288DR180-IINorth East Monitoring, Inc.2000—

Also cleared against K001288: 2 other devices →

What descends from it? (59)

See all 59

6 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K032466SpiderviewEla Medical, Inc.200356
K042108Vista PlusNovacor200546
K102723Model 950-12L Holter Recorder Without AnalysisMemtec Corp.20103
K140847Cardiospy Ecg Holter SystemsLabtech Kft.20141
K122272CardiomemGetemed Medizin- Und Informationstechnik AG20130
K051686Cardiomem CM 3000-12Getemed Medizin- Und Informationstechnik AG20050

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.

What does this lineage say?

  • Its one ancestor has no recall.
  • Of its descendants, K032466 (Ela Medical, Inc., 2003) has gone furthest, with 56 descendants of its own.
  • 2 other devices also cite its predicate K001288.

How does its category compare?

All DSH devices

DSH Recorder, Magnetic Tape, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DSH

4in 2025

2007: 12008: 12009: 32010: 22011: 62012: 22013: 22014: 12015: 22016: 22017: 32018: 32019: 32020: 42021: 42022: 42023: 62024: 22025: 42026 (partial year): 2
2007high 6 (2011) · low 1 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DSH

205in 2025

2009: 84 days median2011: 64 days median2017: 91 days median2018: 269 days median2019: 30 days median2020: 122 days median2021: 263 days median2022: 427 days median2023: 198 days median2025: 205 days median
2007high 427 (2022) · low 30 (2019)2026

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

Recalls per year · DSH

No recall names DSH since 2007.

Adverse event reports per year · DSH

213in 2025

2009: 12010: 82011: 32012: 12013: 22014: 32015: 82016: 62017: 312018: 302019: 762020: 912021: 1132022: 462023: 652024: 882025: 213
2007high 213 (2025) · low 0 (2007)2025

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

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—00
20081—00
200938401
20102—08
201166403
20122—01
20132—02
20141—03
20152—08
20162—06
2017391031
20183269030
2019330076
20204122091
202142630113
20224427046
20236198065
20242—088
202542050213
20262—0—

What is it indicated for?

Detection of Arrhythmia. The Rozinn 153+ is indicated for use in continuous monitoring of Cardiac rhythm when intermittent arrhythmia are suspected due to patient symptoms such as palpitations, transient ischemic attacks, syncope, and the symptoms as determined by the physician. Efficacy of treatment using the 153+ is indicated for use to determine whether current pharmacological treatment (s) of known arrhythmia is effective by measuring the frequency…

Read the full statement (117 words)

Detection of Arrhythmia. The Rozinn 153+ is indicated for use in continuous monitoring of Cardiac rhythm when intermittent arrhythmia are suspected due to patient symptoms such as palpitations, transient ischemic attacks, syncope, and the symptoms as determined by the physician. Efficacy of treatment using the 153+ is indicated for use to determine whether current pharmacological treatment (s) of known arrhythmia is effective by measuring the frequency and duration of the arrhythmia compared to the frequency and duration prior to treatment. Pacemaker evaluation is also indicated for use to evaluate the function of implanted pacemakers to insure that the pacemaker is functioning within prescribed limits. This device is to be used only by the order of a physician

Indications for use as stated in the FDA summary.

Also cleared against K001288

2 other devices cite the same predicate.

  • K102723Model 950-12L Holter Recorder Without AnalysisMemtec Corp. · 2010
  • K041901SD360 Digital Recorder/SD360 Holter Digital RecorderNorth East Monitoring, Inc. · 2004

More from Rozinn Electronics, Inc.

6 FDA decisions under this applicant name. See the company

  • K061780Telephone Electrocardiograph Transmitter and Receiver, TTM for Windows +Rozinn Electronics, Inc. · 2006
  • K042463Holter PlusRozinn Electronics, Inc. · 2004
  • K021517Abp for WindowsRozinn Electronics, Inc. · 2002
  • K020213Netlink/NetscanRozinn Electronics, Inc. · 2002
  • K903331Rozinn 151Rozinn Electronics, Inc. · 1990

Recent decisions in DSH

The DSH category page

  • K260157LifeLens Physiological MonitorLifeLens Technologies, Inc. · 2026
  • K252389Rhythm Master ECG Patch (HM-15BB-AX, HM-15BW-AX, HM-15BW-DX)Smwmed, Inc. · 2026
  • K253293VitaloJAK Clinic (Model 7100)Vitalograph, Ltd. · 2025
  • K243650Zio® monitor (DFG0001)iRhythm Technologies, Inc. · 2025
  • K243603AeviceMDAevice Health Pte., Ltd. · 2025

https://510kreport.com/device/K022540 · printed Nov 6, 2026

Cite this page

510(k) Report. “K022540: Cardio ID+(RZ153+).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022540

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026