510(k) · Cleared

Cleared

Ergoselect 100 K/P, Ergoselect 200 K/P

K053078510(k) TraditionalCleared Apr 27, 2006176-day reviewClass II21 CFR 890.5360

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

Ergoline GmbH · ISD Exerciser, Measuring

Cleared on Apr 27, 2006 as substantially equivalent to K851097 (Lode Corp., 1985) after a 176-day review. Its family tree reaches back 1 generation to 1985. 1 later device descends from it.

Decided: Apr 27, 2006
Review: 176 days
Class: Class II
Product code: ISD
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K851097 (1985). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK851097 Lode Model Corival ErgometerLode Corp. · 1985
This deviceK053078 Ergoselect 100 K/P, Ergoselect 200 K/PErgoline GmbH · 2006
Descendant · cites it directly · 0 of its ownK112121 Ergoselect/GEErgoline GmbH · 2012

Most influential descendants

Showing 1 of 1 · See all

K112121Ergoselect/GEErgoline GmbH · 2012 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K851097	Lode Model Corival Ergometer	Lode Corp.	1985	—
0 (this device)	K053078	Ergoselect 100 K/P, Ergoselect 200 K/P	Ergoline GmbH	2006	—
+1	K112121	Ergoselect/GE	Ergoline GmbH	2012	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2012	1	0

FIG. 1 — Lineage of K053078, 1985–2012Source: FDA 510(k) summaries, read by 510(k) Report · 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 ISD? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin 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.

Type	Number	Device	Applicant	Decided	Recalls
*	K851097	Lode Model Corival Ergometer Summary page 1 …100 K/P; Ergoselect 200 K/P Common name:Ergometer Classification: 890.5360 3.) Substantial Equivalence: Substantial Equivalence is claimed to the following device K851097 4.) Description of device Physiotherapy in redevelopment of muscles for restoration of motion to joints or for use as an adjunc…	Lode Corp.	1985	—

Also cleared against K851097: 1 other device →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K112121	Ergoselect/GE	Ergoline GmbH	2012	0

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, K112121 (Ergoline GmbH, 2012) has gone furthest, with 0 descendants of its own.
1 other device also cites its predicate K851097.

How does its category compare?

All ISD devices

ISD Exerciser, Measuring: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · ISD

1in 2020

2007high 1 (2008) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · ISD

Too few ISD 510(k)s in any year since 2007 to give a median.

Recalls per year · ISD

1in 2013

2007high 1 (2013) · low 0 (2007)2026

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

Adverse event reports per year · ISD

2in 2025

2007high 4 (2023) · low 0 (2007)2025

MAUDE reports naming product code ISD, 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	0	—	0	0
2008	1	—	0	0
2009	0	—	0	1
2010	0	—	0	0
2011	0	—	0	0
2012	1	—	0	1
2013	0	—	1	1
2014	0	—	0	0
2015	1	—	0	1
2016	0	—	0	0
2017	0	—	0	1
2018	0	—	0	2
2019	1	—	0	1
2020	1	—	0	0
2021	0	—	0	1
2022	0	—	0	0
2023	0	—	0	4
2024	0	—	0	0
2025	0	—	0	2
2026	0	—	0	—

What is it indicated for?

Physiotherapy in redevelopment of muscles for restoration of motion to joints or for use as an adjunct

treatment for obesity.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K053078 · printed Nov 6, 2026

Cite this page

510(k) Report. “K053078: Ergoselect 100 K/P, Ergoselect 200 K/P.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K053078

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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