510(k) Report

510(k) · Cleared

Cleared

Infant Flow Ncpap Masks

K984254510(k) TraditionalCleared Feb 24, 199989-day reviewClass II21 CFR 868.5905

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

Sensor Medics Corp. · BZD Ventilator, Non-Continuous (Respirator)

Cleared on Feb 24, 1999 as substantially equivalent to K962848 (Hans Rudolph, Inc., 1996) and 3 other predicates after an 89-day review. Its family tree reaches back 1 generation to 1995. 2 later devices descend from it.

Decided
Feb 24, 1999
Review
89 days
Class
Class II
Product code
BZD
Recalls
None
Predicates
4

Its longest line of descent runs back 1 generation to K945740 (1995). 4 ancestors in all. 2 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1998: 1 other ancestor1996: 2 other ancestors2001: 1 descendant cleared2003: 1 descendant clearedK945740 · Infant Flow System · Hamilton Medical, Inc. · 1995 · recalled1995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors 1 generation forward: 2 descendants K945740 · Infant Flow System · Hamilton Medical, Inc. · 1995 · recalled0
  1. Root · 1 generation backK945740 Infant Flow SystemHamilton Medical, Inc. · 1995 · Recalled
  2. This deviceK984254 Infant Flow Ncpap MasksSensor Medics Corp. · 1999
  3. Descendant · cites it directly · 0 of its ownK030563 Arabella Ncpap MasksHamilton Medical AG · 2003
  4. Descendant · cites it directly · 0 of its ownK012034 Modification to: Sipap Infant Nasal Cpap CircuitSensor Medics Corp. · 2001

Most influential descendants

Showing 2 of 2 · See all
  • K030563Arabella Ncpap MasksHamilton Medical AG · 2003 · cites it directly0descendants
  • K012034Modification to: Sipap Infant Nasal Cpap CircuitSensor Medics Corp. · 2001 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K945740Infant Flow SystemHamilton Medical, Inc.19953
0 (this device)K984254Infant Flow Ncpap MasksSensor Medics Corp.1999—
+1K030563Arabella Ncpap MasksHamilton Medical AG2003—
+1K012034Modification to: Sipap Infant Nasal Cpap CircuitSensor Medics Corp.2001—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199620
199810

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200110
200310
FIG. 1 — Lineage of K984254, 1995–2003Source: 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), 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 BZD? 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 BZD device

  1. #1 K250624 myAirscore 15.7 · 12 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (4)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K962848Hans Rudolph Nasal Cpap Mask
Summary page 1
…System in place of the standard nasal prongs. Clinical and Non-Clinical Tests of Equivalency: The Infant Flow Mask is similar in purpose to the Hans Rudoiph CPAP Mask (K962848) and provides the same function as the nasal CPAP prongs of the SensorMedics Infant Flow System (K974303) and Hamilton Aladdin CP…
Hans Rudolph, Inc.1996—
*K974303Infant Flow System
Summary page 1
…t Flow Mask is similar in purpose to the Hans Rudoiph CPAP Mask (K962848) and provides the same function as the nasal CPAP prongs of the SensorMedics Infant Flow System (K974303) and Hamilton Aladdin CPAP System (K960359 and K945740). Because there are no differences other than facial mounting and labelin…
Sensor Medics Corp.1998—
*K960359Aladdin Monitoring Oxygen/Air Mixer
Summary page 1
…ns Rudoiph CPAP Mask (K962848) and provides the same function as the nasal CPAP prongs of the SensorMedics Infant Flow System (K974303) and Hamilton Aladdin CPAP System (K960359 and K945740). Because there are no differences other than facial mounting and labeling between the SensorMedics Infant Flow Syst…
Hamilton Medical, Inc.1996—
*K945740Infant Flow System
Summary page 1
…PAP Mask (K962848) and provides the same function as the nasal CPAP prongs of the SensorMedics Infant Flow System (K974303) and Hamilton Aladdin CPAP System (K960359 and K945740). Because there are no differences other than facial mounting and labeling between the SensorMedics Infant Flow System prongs an…
Hamilton Medical, Inc.19953

What descends from it? (2)

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

NumberDeviceApplicantDecidedDescendants
K030563Arabella Ncpap MasksHamilton Medical AG20030
K012034Modification to: Sipap Infant Nasal Cpap CircuitSensor Medics Corp.20010

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?

  • 1 of the 4 ancestors has a recall of any class.
  • Of its descendants, K030563 (Hamilton Medical AG, 2003) has gone furthest, with 0 descendants of its own.

How does its category compare?

All BZD devices

BZD Ventilator, Non-Continuous (Respirator): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · BZD

7in 2025

2007: 212008: 172009: 232010: 122011: 232012: 212013: 232014: 142015: 112016: 122017: 52018: 52019: 62020: 62021: 62022: 42023: 52024: 102025: 72026 (partial year): 10
2007high 23 (2009) · low 4 (2022)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · BZD

189in 2025

2007: 83 days median2008: 108 days median2009: 90 days median2010: 122 days median2011: 125 days median2012: 133 days median2013: 127 days median2014: 172 days median2015: 224 days median2016: 217 days median2017: 221 days median2018: 280 days median2019: 231 days median2020: 137 days median2021: 192 days median2022: 253 days median2023: 204 days median2024: 132 days median2025: 189 days median2026 (partial year): 214 days median
2007high 280 (2018) · low 83 (2007)2026

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

Recalls per year · BZD

8in 2023

2007: 292008: 22009: 12011: 12019: 4, 4 Class I2023: 8, 7 Class I2026 (partial year): 2, 2 Class I
2007high 29 (2007) · low 0 (2010)2026

Class I (13 since 2007) Class II/III not classified

Adverse event reports per year · BZD

60,279in 2025

2007: 652008: 672009: 1472010: 1432011: 1892012: 1392013: 822014: 862015: 1142016: 1182017: 1482018: 1012019: 1882020: 1262021: 6,0662022: 90,7682023: 27,9872024: 68,2622025: 60,279
2007high 90,768 (2022) · low 65 (2007)2025

MAUDE reports naming product code BZD, 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
200721832965
200817108267
200923901147
2010121220143
2011231251189
2012211330139
201323127082
201414172086
2015112240114
2016122170118
201752210148
201852800101
201962314 (4)188
202061370126
2021619206,066
20224253090,768
202352048 (7)27,987
202410132068,262
20257189060,279
2026102142 (2)—

What is it indicated for?

The SensorMedics Infant Flow NCPAP Masks are intended for use with the SensorMedics Infant Flow System, consisting of a Driver and NCPAP Generator. It is intended to provide CPAP with a nasal mask for use in hospitals to treat newboms and infants with RDS or who are recovering from RDS.

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

More from Sensor Medics Corp.

29 FDA decisions under this applicant name. See the company

  • K032516HIOX80 Aerosol AdapterSensor Medics Corp. · 2004
  • K031745Infant Flow Plus Infant Cpap System with Sipap FunctionSensor Medics Corp. · 2004
  • K031883Lyra Nasal MaskSensor Medics Corp. · 2003
  • K030943Modification to HioxSensor Medics Corp. · 2003
  • K022192Pegasus Nasal Cpap SystemSensor Medics Corp. · 2003

Recent decisions in BZD

The BZD category page

  • K260251BreathCare PAP III (YH-390N)Suzhou Yuyue Medical Technology Co., Ltd. · 2026
  • K261262Altis Full Face MaskRespironics, Inc. · 2026
  • K253044RXiBreeze PAP System (RXiBreeze 20C)Resvent Medical Technology Co., Ltd. · 2026
  • K253553OrionResmed Corp · 2026
  • K254104ResScan EssentialsResmed Corp · 2026

https://510kreport.com/device/K984254 · printed Nov 5, 2026

Cite this page

510(k) Report. “K984254: Infant Flow Ncpap Masks.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K984254

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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