510(k) Report

510(k) · Cleared

Cleared

Rembrandt System

K962865510(k) TraditionalCleared Oct 25, 199694-day reviewClass II21 CFR 868.2377

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

Airsep Corp. · FLS Monitor, Apnea, Facility Use

Cleared on Oct 25, 1996 after a 94-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 98 later devices descend from it.

Decided
Oct 25, 1996
Review
94 days
Class
Class II
Product code
FLS
Recalls
None
Predicates
0

98 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2004: 2 descendants cleared2017: 5 descendants cleared2008: 3 descendants cleared2006: 1 descendant cleared2010: 2 descendants cleared2013: 6 descendants cleared2007: 1 descendant cleared2009: 3 descendants cleared2025: 14 descendants cleared2015: 3 descendants cleared2012: 2 descendants cleared2022: 7 descendants cleared2021: 4 descendants cleared2011: 2 descendants cleared2016: 5 descendants cleared2014: 3 descendants cleared2020: 6 descendants cleared2018: 4 descendants cleared2023: 5 descendants cleared2026: 10 descendants cleared2019: 7 descendants cleared2024: 3 descendants cleared1995200020052010201520202025
  1. This deviceK962865 Rembrandt SystemAirsep Corp. · 1996
  2. Descendant · cites it directly · 54 of its ownK041904 Compass F10 SystemMedcare Flaga · 2004
  3. Descendant · 2 generations on · 41 of its ownK073682 Embletta GoldEmbla Systems, Inc. · 2008 · Recalled
  4. Descendant · cites it directly · 41 of its ownK041724 Compass M10 SystemMedcare Flaga · 2004
  5. Descendant · 2 generations on · 30 of its ownK061405 Apnealink, Model 22302Resmed Germany, Inc. · 2006
  6. Descendant · 3 generations on · 29 of its ownK070263 ApnealinkResmed Germany, Inc. · 2007

Showing 5 of 98 descendants. See all descendants

Descendants cleared per year

2004: 22006: 12007: 12008: 32009: 32010: 22011: 22012: 22013: 62014: 32015: 32016: 52017: 52018: 42019: 72020: 62021: 42022: 72023: 52024: 32025: 142026: 10
2004high 14 (2025) · low 0 (2005)2026

Most influential descendants

Showing 5 of 98 · See all
  • K041904Compass F10 SystemMedcare Flaga · 2004 · cites it directly54descendants
  • K073682Embletta GoldEmbla Systems, Inc. · 2008 · 2 generations on41descendants
  • K041724Compass M10 SystemMedcare Flaga · 2004 · cites it directly41descendants
  • K061405Apnealink, Model 22302Resmed Germany, Inc. · 2006 · 2 generations on30descendants
  • K070263ApnealinkResmed Germany, Inc. · 2007 · 3 generations on29descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K962865Rembrandt SystemAirsep Corp.1996—
+1K041904Compass F10 SystemMedcare Flaga2004—
+2K073682Embletta GoldEmbla Systems, Inc.20081
+1K041724Compass M10 SystemMedcare Flaga2004—
+2K061405Apnealink, Model 22302Resmed Germany, Inc.2006—
+3K070263ApnealinkResmed Germany, Inc.2007—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200420
200610
200710
200830
200930
201020
201120
201220
201360
201430
201530
201650
201750
201840
201970
202060
202140
202270
202350
202430
2025140
2026100
FIG. 1 — Lineage of K962865, 1996–2026Source: 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in FLS? 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (98)

See all 98

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

NumberDeviceApplicantDecidedDescendants
K041904Compass F10 SystemMedcare Flaga200454
K041724Compass M10 SystemMedcare Flaga200441
K163617REMbrandtEmbla Systems20170

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?

  • Of its descendants, K041904 (Medcare Flaga, 2004) has gone furthest, with 54 descendants of its own.

How does its category compare?

All FLS devices

FLS Monitor, Apnea, Facility Use: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FLS

FDA has decided no FLS device since 2007.

Median 510(k) review, days · FLS

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

Recalls per year · FLS

1in 2009

2007: 12009: 1
2007high 1 (2007) · low 0 (2008)2026

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

Adverse event reports per year · FLS

1in 2019

2007: 52008: 32009: 62010: 142011: 212012: 132013: 152014: 102015: 122016: 32018: 42019: 1
2007high 21 (2011) · low 0 (2017)2025

MAUDE reports naming product code FLS, 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
20070—15
20080—03
20090—16
20100—014
20110—021
20120—013
20130—015
20140—010
20150—012
20160—03
20170—00
20180—04
20190—01
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

More from Airsep Corp.

18 FDA decisions under this applicant name. See the company

  • K101154Centrox, Reliant, Ultrox, as-D+, as-E, as-G, as-J, as-K and as-LAirsep Corp. · 2011
  • K080348Oxiscan II Data Management SystemAirsep Corp. · 2008
  • K020324Lifestyle Oxygen ConcentratorAirsep Corp. · 20023 recalls
  • K012037Healthlife Oxygen Concentrator Model AS009Airsep Corp. · 2002
  • K000963DA Vinchi Eeg and Emg/EP SystemsAirsep Corp. · 2000

Recent decisions in FLS

The FLS category page

  • K011597Smartmonitor 2, Model 4000Respironics Georgia, Inc. · 20022 recalls
  • K991087Hannah Wireless Vital Signs MonitorIlife Systems, Inc. · 2000
  • K951246Propaq Encore 200 Series Monitor with Neonatal Mode and Impedance Pneumography OptionsProtocol Systems, Inc. · 1996
  • K894973Respitrace PlusHogan & Hartson · 1989
  • K832999Respiration MonitorLitton Medical Electronics · 1984

https://510kreport.com/device/K962865 · printed Nov 5, 2026

Cite this page

510(k) Report. “K962865: Rembrandt System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K962865

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026