510(k) Report

510(k) · Cleared

Cleared

Aqua+I-F, I-H, I-FH, II-H, II-FH, Iii-H

K945359510(k) TraditionalCleared Feb 21, 1995111-day reviewClass I21 CFR 868.5375

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

Artema Medical AB · BYD Condenser, Heat And Moisture (Artificial Nose)

Cleared on Feb 21, 1995 after a 111-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 2 of the 6 devices in its family, counting itself, have a Class I recall. 5 later devices descend from it.

Decided
Feb 21, 1995
Review
111 days
Class
Class I
Product code
BYD
Recalls
None
Predicates
0

5 later devices descend from it, 1 citing it directly. 2 of the 6 devices in this family, counting this one, have a Class I recall.

Descendants, by year cleared 2002: 1 descendant cleared2008: 1 descendant cleared, 1 with a Class I recall12014: 1 descendant cleared2009: 1 descendant cleared2022: 1 descendant cleared, 1 with a Class I recall11995200020052010201520202025
  1. This deviceK945359 Aqua+I-F, I-H, I-FH, II-H, II-FH, Iii-HArtema Medical AB · 1995
  2. Descendant · cites it directly · 4 of its ownK014282 Bacstop Filter,Bacstop Filter/HmeMunktell Filter AB · 2002
  3. Descendant · 2 generations on · 3 of its ownK072002 Filter Carestar 30; Filter Safestar 55; Filter/Hme Twinstar 55Draeger Medical AG & Co. KG · 2008 · Recalled (Class I)
  4. Descendant · 3 generations on · 1 of its ownK132709 VR Medical Heat and Moisture Exchanger and FilterVr Medical · 2014
  5. Descendant · 4 generations on · 0 of its ownK221836 Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar PlusDrägerwerk AG & Co. KGaA · 2022 · Recalled (Class I)
  6. Descendant · 3 generations on · 0 of its ownK090738 Thermoflo HCH, Thermoflo FilterArc Medical, Inc. · 2009

Class I recalls in this family

  • K072002 Filter Carestar 30; Filter Safestar 55…2 generations on · 2008
  • K221836 Filter CareStar Plus, Filter SafeStar Plus…4 generations on · 2022

Most influential descendants

Showing 5 of 5 · See all
  • K014282Bacstop Filter,Bacstop Filter/HmeMunktell Filter AB · 2002 · cites it directly4descendants
  • K072002Filter Carestar 30; Filter Safestar 55; Filter/Hme Twinstar 55Draeger Medical AG & Co. KG · 2008 · 2 generations on3descendants
  • K132709VR Medical Heat and Moisture Exchanger and FilterVr Medical · 2014 · 3 generations on1descendant
  • K221836Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar PlusDrägerwerk AG & Co. KGaA · 2022 · 4 generations on0descendants
  • K090738Thermoflo HCH, Thermoflo FilterArc Medical, Inc. · 2009 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K945359Aqua+I-F, I-H, I-FH, II-H, II-FH, Iii-HArtema Medical AB1995—
+1K014282Bacstop Filter,Bacstop Filter/HmeMunktell Filter AB2002—
+2K072002Filter Carestar 30; Filter Safestar 55; Filter/Hme Twinstar 55Draeger Medical AG & Co. KG2008Class I
+3K132709VR Medical Heat and Moisture Exchanger and FilterVr Medical2014—
+4K221836Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar PlusDrägerwerk AG & Co. KGaA2022Class I
+3K090738Thermoflo HCH, Thermoflo FilterArc Medical, Inc.2009—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
200811
200910
201410
202211
FIG. 1 — Lineage of K945359, 1995–2022Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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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.

2 devices in this family have a Class I recall. 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (5)

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

NumberDeviceApplicantDecidedDescendants
K014282Bacstop Filter,Bacstop Filter/HmeMunktell Filter AB20024

Has anything in its family been recalled? (2 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

  • K072002Filter Carestar 30; Filter Safestar 55; Filter/Hme Twinstar 55Draeger Medical AG & Co. KG · 2008 · 2 generations on · ◆ in the 2008 descendants bar of FIG. 11 Class I recall
  • K221836Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar PlusDrägerwerk AG & Co. KGaA · 2022 · 4 generations on · ◆ in the 2022 descendants bar of FIG. 14 Class I recalls

What does this lineage say?

  • Of its descendants, K014282 (Munktell Filter AB, 2002) has gone furthest, with 4 descendants of its own.

How does its category compare?

All BYD devices

BYD Condenser, Heat And Moisture (Artificial Nose): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · BYD

FDA has decided no BYD device since 2007.

Median 510(k) review, days · BYD

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

Recalls per year · BYD

3in 2024

2011: 12014: 1, 1 Class I2015: 1, 1 Class I2020: 12024: 3
2007high 3 (2024) · low 0 (2007)2026

Class I (2 since 2007) Class II/III not classified

Adverse event reports per year · BYD

52in 2025

2007: 42008: 22009: 22010: 92011: 72012: 42013: 42014: 62015: 172016: 182017: 122018: 332019: 152020: 352021: 152022: 322023: 452024: 102025: 52
2007high 52 (2025) · low 2 (2008)2025

MAUDE reports naming product code BYD, 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—04
20080—02
20090—02
20100—09
20110—17
20120—04
20130—04
20140—1 (1)6
20150—1 (1)17
20160—018
20170—012
20180—033
20190—015
20200—135
20210—015
20220—032
20230—045
20240—310
20250—052
20260—0—

More from Artema Medical AB

5 FDA decisions under this applicant name. See the company

  • K912333Artema Aqua+Artema Medical AB · 1991
  • K912336Artema Aqua+ FlexArtema Medical AB · 1991
  • K912335Artema Aqua+ NArtema Medical AB · 1991
  • K912334Artema Aqua+ T & TSArtema Medical AB · 1991

Recent decisions in BYD

The BYD category page

  • K955008Heat & Moisture ExchangerIntertech Resources, Inc. · 1996
  • K954194Disposable Hme/FilterEngstrom Medical · 1995
  • K953580Heat Moisture ExchangerIntertech Resources, Inc. · 1995
  • K953507Type 1 & 2 (Humidair I & II)Icor AB · 1995
  • K953620Warm N Wet Hmef W/Luer AdapterHospitak, Inc. · 1995

https://510kreport.com/device/K945359 · printed Nov 4, 2026

Cite this page

510(k) Report. “K945359: Aqua+I-F, I-H, I-FH, II-H, II-FH, Iii-H.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K945359

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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