510(k) · Cleared

Cleared

Medipalm-20

K031202510(k) TraditionalCleared May 1, 200315-day reviewClass II21 CFR 882.1400

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

Braebon Medical Corp. · OLV Standard Polysomnograph With Electroencephalograph

Cleared on May 1, 2003 as substantially equivalent to K001013 (Airsep Corp., 2000) and 4 other predicates after a 15-day review. Its family tree reaches back 2 generations to 1998. 48 later devices descend from it.

Decided: May 1, 2003
Review: 15 days
Class: Class II
Product code: OLV
Recalls: None
Predicates: 6

Its longest line of descent runs back 2 generations to K981445 (1998). 6 ancestors in all. 48 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 2 generations backK981445 Ultima Airflow Sensor, 0510Braebon Medical Corp. · 1998
1 generation backK984431 Ultima Airflow Pressure SensorBraebon Medical Corp. · 1998
This deviceK031202 Medipalm-20Braebon Medical Corp. · 2003
Descendant · cites it directly · 41 of its ownK073682 Embletta GoldEmbla Systems, Inc. · 2008 · Recalled
Descendant · 2 generations on · 27 of its ownK122516 Embletta MPREmbla Systems · 2013 · Recalled
Descendant · 3 generations on · 20 of its ownK161579 Watch-PAT200UItamar Medical, Ltd. · 2017
Descendant · 4 generations on · 12 of its ownK180775 Watch-PAT300Itamar Medical, Ltd. · 2018
Descendant · 2 generations on · 7 of its ownK090273 Kai Sensors Non-Contact Respiratory Rate Spot Check, Model 100, Kai…Kai Sensors, Inc. · 2009

Showing 5 of 48 descendants. See all descendants

Descendants cleared per year

2006high 9 (2025) · low 0 (2007)2026

Most influential descendants

Showing 5 of 48 · See all

K073682Embletta GoldEmbla Systems, Inc. · 2008 · cites it directly41descendants
K122516Embletta MPREmbla Systems · 2013 · 2 generations on27descendants
K161579Watch-PAT200UItamar Medical, Ltd. · 2017 · 3 generations on20descendants
K180775Watch-PAT300Itamar Medical, Ltd. · 2018 · 4 generations on12descendants
K090273Kai Sensors Non-Contact Respiratory Rate Spot Check, Model 100, Kai Rspot, Model 100Kai Sensors, Inc. · 2009 · 2 generations on7descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K981445	Ultima Airflow Sensor, 0510	Braebon Medical Corp.	1998	—
−1	K984431	Ultima Airflow Pressure Sensor	Braebon Medical Corp.	1998	—
0 (this device)	K031202	Medipalm-20	Braebon Medical Corp.	2003	—
+1	K073682	Embletta Gold	Embla Systems, Inc.	2008	1
+2	K122516	Embletta MPR	Embla Systems	2013	1
+3	K161579	Watch-PAT200U	Itamar Medical, Ltd.	2017	—
+4	K180775	Watch-PAT300	Itamar Medical, Ltd.	2018	—
+2	K090273	Kai Sensors Non-Contact Respiratory Rate Spot Check, Model 100, Kai Rspot…	Kai Sensors, Inc.	2009	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1999	1	0
2000	2	0
2001	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2006	1	0
2008	2	0
2009	2	0
2010	1	0
2011	1	0
2013	2	0
2015	1	0
2016	1	0
2017	2	0
2018	2	0
2019	2	0
2020	2	0
2021	2	0
2022	6	0
2023	5	0
2024	2	0
2025	9	0
2026	5	0

FIG. 1 — Lineage of K031202, 1998–2026Source: 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 OLV? 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 OLV device

#1 K241288 Noxturnal Webscore 17.3 · 10 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? (6)

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
*	K001013	Monet Acquisition System for Eeg and Polysomnography Summary page 2 …oes not contain any patient contacting malerials. 7.0 Predicate Device Equivalence We are claiming substantial equivalence to the following devices: Airsep Corp. Monet K001013 EB Neuro. S.P.A. Sandman DBigital K003154 Nellcor Puritan Bennstt Suzanne K990565 Nonin Medical, Inc. PalmSAT, Model 2500 Pulse O…	Airsep Corp.	2000	—
*	K003154	Mizar, Basis BE, Sandman Digital Summary page 2 …erials. 7.0 Predicate Device Equivalence We are claiming substantial equivalence to the following devices: Airsep Corp. Monet K001013 EB Neuro. S.P.A. Sandman DBigital K003154 Nellcor Puritan Bennstt Suzanne K990565 Nonin Medical, Inc. PalmSAT, Model 2500 Pulse Oximeter with finger prebes K0026%0 BRAEBON…	Eb Neuro S.P.A.	2001	—
*	K990565	Suzanne Summary page 2 …e We are claiming substantial equivalence to the following devices: Airsep Corp. Monet K001013 EB Neuro. S.P.A. Sandman DBigital K003154 Nellcor Puritan Bennstt Suzanne K990565 Nonin Medical, Inc. PalmSAT, Model 2500 Pulse Oximeter with finger prebes K0026%0 BRAEBON Medical Corporation Ultima Smartbelt K0…	Nellcor Puritan Bennett, Inc.	1999	—
Kept off the family tree	K002690	FDA’s K002690 is Model 2500, Palmsat Hand Held Pulse Oximeter, Model 2500 Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree	Nonin Medical, Inc.	2000	2
*	K001743	Ultima Smartbelt, Model 0560 Summary page 2 …54 Nellcor Puritan Bennstt Suzanne K990565 Nonin Medical, Inc. PalmSAT, Model 2500 Pulse Oximeter with finger prebes K0026%0 BRAEBON Medical Corporation Ultima Smartbelt K001743 BRAEBON Medical Corporation Ultima Airflow Pressure Sensor K984431 8.0 Similarities and Differences Between Subject and Predicat…	Braebon Medical Corp.	2000	—
*	K984431	Ultima Airflow Pressure Sensor Summary page 2 …SAT, Model 2500 Pulse Oximeter with finger prebes K0026%0 BRAEBON Medical Corporation Ultima Smartbelt K001743 BRAEBON Medical Corporation Ultima Airflow Pressure Sensor K984431 8.0 Similarities and Differences Between Subject and Predicate Devices Intended Use No difference Indicalions Statement No diff…	Braebon Medical Corp.	1998	—

What descends from it? (48)

See all 48

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

Number	Device	Applicant	Decided	Descendants
K073682	Embletta Gold	Embla Systems, Inc.	2008	41
K071782	Micromed Brain Spy Plus, Embia Titanium Devices	Micromed S.P.A.	2008	4
K061764	Medibyte, Model MP8	Braebon Medical Corp.	2006	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 5 years and passes through 1 company; a new generation was cleared every 4.3 years on median.
None of the 6 ancestors has a recall.
Of its descendants, K073682 (Embla Systems, Inc., 2008) has gone furthest, with 41 descendants of its own.

How does its category compare?

All OLV devices

OLV Standard Polysomnograph With Electroencephalograph: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · OLV

1in 2025

2007high 3 (2017) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OLV

141in 2018

2007high 141 (2018) · low 83 (2017)2026

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

Recalls per year · OLV

No recall names OLV since 2007.

Adverse event reports per year · OLV

1in 2025

2007high 4 (2016) · low 0 (2007)2025

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

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	0
2008	2	—	0
2009	0	—	0
2010	1	—	0
2011	2	—	0
2012	0	—	0
2013	1	—	1
2014	0	—	0
2015	1	—	0
2016	0	—	4
2017	3	83	0
2018	3	141	3
2019	0	—	1
2020	2	—	0
2021	0	—	3
2022	1	—	3
2023	0	—	2
2024	2	—	2
2025	1	—	1
2026	2	—	—

What is it indicated for?

The MEDIPalm-20™ is a portable data recorder used to collect physiological signals for transfer to an FDA-cleared polysomnographic analysis station capable of reading European Data Format (.edf) files.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K031202 · printed Nov 4, 2026

Cite this page

510(k) Report. “K031202: Medipalm-20.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K031202

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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