510(k) · Cleared

Recalled · Class II · 2012

Datacaptor System

K113835510(k) TraditionalCleared Jun 27, 2012183-day reviewClass II21 CFR 870.2300Recalls 1

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

Capsule Tech, Inc. · MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)

Cleared on Jun 27, 2012 as substantially equivalent to K013019 (Capsule Technologie, 2001) and 2 other predicates after a 183-day review. Its family tree reaches back 4 generations to 2000. It has been recalled once.

Decided: Jun 27, 2012
Review: 183 days
Class: Class II
Product code: MWI
Recalls: 1
Predicates: 3

Its longest line of descent runs back 4 generations to K000635 (2000). No later device cites it as a predicate yet.

By dateBy generation

Root · 4 generations backK000635 Modification to HP M2376A Device Link SystemAgilent Technologies, Inc. · 2000
3 generations backK013019 DatacaptorCapsule Technologie · 2001 · Recalled
2 generations backK020197 Modification to DatacaptorCapsule Technologie · 2002 · Recalled
1 generation backK032142 DatacaptorCapsule Technologie · 2003 · Recalled
This deviceK113835 Datacaptor SystemCapsule Tech, Inc. · 2012

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K000635	Modification to HP M2376A Device Link System	Agilent Technologies, Inc.	2000	—
−3	K013019	Datacaptor	Capsule Technologie	2001	2
−2	K020197	Modification to Datacaptor	Capsule Technologie	2002	2
−1	K032142	Datacaptor	Capsule Technologie	2003	2
0 (this device)	K113835	Datacaptor System	Capsule Tech, Inc.	2012	—

FIG. 1 — Lineage of K113835, 2000–2012Source: 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 MWI? 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 MWI device

#1 K230457 Empatica Health Monitoring Platform…score 28.0 · 39 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
*	K013019	Datacaptor Summary page 1 …ometer and rate alarm) - 21 CER 870.2 300 CA Substantial EquivalenceClaimed to Predicate Device DataCaptor'" System as cleared via one Traditional 510(k), K013019, and two subsequent Special…	Capsule Technologie	2001	2
*	K020197	Modification to Datacaptor Summary page 1 …e Traditional 510(k), K013019, and two subsequent Special 510(k)s, K020197, and K032142 C.5 DeviceDescription The DataCaptor TM 1 System consists of DataCaptor' Connectivity Software a data…	Capsule Technologie	2002	2
*	K032142	Datacaptor Summary page 1 …510(k), K013019, and two subsequent Special 510(k)s, K020197, and K032142 C.5 DeviceDescription The DataCaptor TM 1 System consists of DataCaptor' Connectivity Software a data acquisition…	Capsule Technologie	2003	2

Also cleared against K013019: 2 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Aug 10, 2012	Class II	Z-2377-2012	Device Design	Capsule Neuron Docking Station may experience a lost connection, resulting in loss of data or loss of power to the Caspsule Neuron

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 12 years and passes through 3 companies; a new generation was cleared every 1.7 years on median.
3 of the 4 ancestors have a recall of any class.
2 other devices also cite its predicate K013019.

How does its category compare?

All MWI devices

MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms): FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.

FDA decisions per year · MWI

4in 2025

2007high 20 (2013) · low 4 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MWI

247in 2025

2007high 255 (2019) · low 42 (2007)2026

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

Recalls per year · MWI

9so far in 2026, the most since 2007

2007high 9 (2026) · low 0 (2016)2026

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

Adverse event reports per year · MWI

182in 2025

2007high 188 (2021) · low 3 (2007)2025

MAUDE reports naming product code MWI, 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	9	42	1	3
2008	9	49	1	3
2009	6	112	2	20
2010	17	58	2	17
2011	11	78	3	16
2012	13	104	5	31
2013	20	85	3	42
2014	16	148	6	30
2015	19	127	1	31
2016	12	165	0	51
2017	13	205	2	85
2018	11	217	0	158
2019	14	255	4	169
2020	8	138	0	110
2021	9	161	0	188
2022	5	231	2	168
2023	8	250	0	179
2024	10	202	5	120
2025	4	247	0	182
2026	6	239	9	—

What is it indicated for?

The DataCaptor System is indicated for use in data collection and clinical information management either directly or through networks with independent bedside devices. DataCaptor m is not intended for monitoring purposes, nor is the software intended to control any of the clinical devices (independent bedside devices / information systems) to which it is connected.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K113835 · printed Nov 6, 2026

Cite this page

510(k) Report. “K113835: Datacaptor System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113835

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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