510(k) · Cleared

Cleared

Respisens

K092845510(k) TraditionalCleared Jan 26, 2010133-day reviewClass II21 CFR 892.5050

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

Nomics · IYE Accelerator, Linear, Medical

Cleared on Jan 26, 2010 as substantially equivalent to K983629 (Varian Medical Systems, Inc., 1999) and 2 other predicates after a 133-day review. Its family tree reaches back 3 generations to 1987. 1 later device descends from it.

Decided: Jan 26, 2010
Review: 133 days
Class: Class II
Product code: IYE
Recalls: None
Predicates: 3

Its longest line of descent runs back 3 generations to K864886 (1987). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 3 generations backK864886 Respigraph-Respisomnograph-RespicentralNims/Respitrace Corp. · 1987
2 generations backK983629 RPM Respiratory Gating SystemVarian Medical Systems, Inc. · 1999
1 generation backK063270 RPM Respiratory Gating SystemVarian Medical Systems, Inc. · 2006 · Recalled
This deviceK092845 RespisensNomics · 2010
Descendant · cites it directly · 0 of its ownK112841 Surface Beacon TranspondersCalypso Medical Technologies, Inc. · 2012

Most influential descendants

Showing 1 of 1 · See all

K112841Surface Beacon TranspondersCalypso Medical Technologies, Inc. · 2012 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K864886	Respigraph-Respisomnograph-Respicentral	Nims/Respitrace Corp.	1987	—
−2	K983629	RPM Respiratory Gating System	Varian Medical Systems, Inc.	1999	—
−1	K063270	RPM Respiratory Gating System	Varian Medical Systems, Inc.	2006	1
0 (this device)	K092845	Respisens	Nomics	2010	—
+1	K112841	Surface Beacon Transponders	Calypso Medical Technologies, Inc.	2012	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2001	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2012	1	0

FIG. 1 — Lineage of K092845, 1987–2012Source: 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 IYE? 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 IYE device

#1 K252977 Halcyon, Ethos Radiotherapy System (5.0)score 18.8 · 18 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? (3)

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
*	K983629	RPM Respiratory Gating System Summary page 1 …Class 11 Product Code - lYE Predicate Devices: RPM Respiratory Gating system (K983629) RPM Respiratory Gating system (K063270) Active…	Varian Medical Systems, Inc.	1999	—
*	K063270	RPM Respiratory Gating System Summary page 1 …uct Code - lYE Predicate Devices: RPM Respiratory Gating system (K983629) RPM Respiratory Gating system (K063270) Active Breathing Coordinator - ABC system (K003330) Device Description: The Respisen…	Varian Medical Systems, Inc.	2006	1
*	K003330	Aktina Medical Physics Corporation Active Breathing Coordinator (Abc) Summary page 1 …629) RPM Respiratory Gating system (K063270) Active Breathing Coordinator - ABC system (K003330) Device Description: The Respisens system monitors patient motion in real time during radiotherapy. The system is based on a t…	Aktina Medical Physics Corp.	2001	—

Also cleared against K983629: 6 other devices →

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
K112841	Surface Beacon Transponders	Calypso Medical Technologies, Inc.	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?

The line of descent spans 23 years and passes through 3 companies; a new generation was cleared every 7.5 years on median.
1 of the 4 ancestors has a recall of any class.
Of its descendants, K112841 (Calypso Medical Technologies, Inc., 2012) has gone furthest, with 0 descendants of its own.
6 other devices also cite its predicate K983629.

How does its category compare?

All IYE devices

IYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.

FDA decisions per year · IYE

12in 2025

2007high 28 (2012) · low 9 (2024)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · IYE

170in 2025

2007high 239 (2024) · low 44 (2007)2026

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

Recalls per year · IYE

1in 2025

2007high 78 (2007) · low 1 (2024)2026

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

Adverse event reports per year · IYE

101in 2025

2007high 280 (2011) · low 66 (2022)2025

MAUDE reports naming product code IYE, 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	23	44	78	155
2008	14	69	49	114
2009	20	63	22	174
2010	23	74	27	246
2011	11	94	73	280
2012	28	106	20	128
2013	18	88	11	96
2014	20	100	14	124
2015	20	108	8	100
2016	21	97	7	97
2017	23	94	7	125
2018	21	58	7	85
2019	19	83	2	91
2020	20	67	4	74
2021	19	86	5	68
2022	12	172	3	66
2023	18	129	7	128
2024	9	239	1	81
2025	12	170	1	101
2026	14	120	4	—

What is it indicated for?

The Respisens system is intended to monitor patient motion in real time during radiotherapy. In particular, the system is intended to monitor breath hold and to detect undesirable patient motion. Monitoring respiratory motion during breath hold is essential in ensuring patient safety. The system warns the operator when breath hold is not maintained properly. Verifying that the patient stays completely still during treatment is also fundamental. The system can detect patient movement and warn the operator when necessary.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K092845 · printed Nov 6, 2026

Cite this page

510(k) Report. “K092845: Respisens.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K092845

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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