510(k) Report

510(k) · Cleared

Cleared

Clarissa Infant Ncpap Cannula

K032922510(k) TraditionalCleared Sep 22, 2004366-day reviewClass II21 CFR 868.5895

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

Airways Ltd., Inc. · CBK Ventilator, Continuous, Facility Use

Cleared on Sep 22, 2004 as substantially equivalent to K811409 (Sherwood Medical Co., 1981) and 4 other predicates after a 366-day review. Its family tree reaches back 1 generation to 1979. 7 later devices descend from it.

Decided
Sep 22, 2004
Review
366 days
Class
Class II
Product code
CBK
Recalls
None
Predicates
5

Its longest line of descent runs back 1 generation to K792018 (1979). 5 ancestors in all. 7 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1989: 1 other ancestor1987: 1 other ancestor1986: 1 other ancestor1981: 1 other ancestor2025: 1 descendant cleared2009: 1 descendant cleared2012: 2 descendants cleared2010: 1 descendant cleared2016: 1 descendant cleared2024: 1 descendant clearedK792018 · Silicone Rubber-BI Nasopharyngeal Air · Vesta, Inc. · 197919801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors 1 generation forward: 2 descendants2 generations forward: 2 descendants3 generations forward: 2 descendants4 generations forward: 1 descendant K792018 · Silicone Rubber-BI Nasopharyngeal Air · Vesta, Inc. · 19790
  1. Root · 1 generation backK792018 Silicone Rubber-BI Nasopharyngeal AirVesta, Inc. · 1979
  2. This deviceK032922 Clarissa Infant Ncpap CannulaAirways Ltd., Inc. · 2004
  3. Descendant · cites it directly · 5 of its ownK090935 Minime Pediatric MaskSleepnet Corporation · 2009
  4. Descendant · 2 generations on · 3 of its ownK102224 Pixi Pediatric MaskResmed, Ltd. · 2010
  5. Descendant · 3 generations on · 1 of its ownK120920 Hsiner Cpap Silicone Nasal Mask Size XS/Petite Hsiner Nasal Pillow…Hsiner Company · 2012
  6. Descendant · cites it directly · 0 of its ownK250651 OptiPAP Junior Flexi Tube US (OPTIPAPFUS); OptiPAP Junior Nasal…Fisher & Paykel Healthcare, Ltd. · 2025
  7. Descendant · 4 generations on · 0 of its ownK243225 Nasal Pillow Mask - Small (NNPM-01/ Nefes S); Nasal Pillow Mask -…Genadyne Biotechnologies, Inc. · 2024

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2009: 12010: 12012: 22016: 12024: 12025: 1
2009high 2 (2012) · low 0 (2011)2026

Most influential descendants

Showing 5 of 7 · See all
  • K090935Minime Pediatric MaskSleepnet Corporation · 2009 · cites it directly5descendants
  • K102224Pixi Pediatric MaskResmed, Ltd. · 2010 · 2 generations on3descendants
  • K120920Hsiner Cpap Silicone Nasal Mask Size XS/Petite Hsiner Nasal Pillow Mask Hsiner Infant…Hsiner Company · 2012 · 3 generations on1descendant
  • K250651OptiPAP Junior Flexi Tube US (OPTIPAPFUS); OptiPAP Junior Nasal Prongs XXS…Fisher & Paykel Healthcare, Ltd. · 2025 · cites it directly0descendants
  • K243225Nasal Pillow Mask - Small (NNPM-01/ Nefes S); Nasal Pillow Mask - Medium (NNPM-02/ Nefes…Genadyne Biotechnologies, Inc. · 2024 · 4 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K792018Silicone Rubber-BI Nasopharyngeal AirVesta, Inc.1979—
0 (this device)K032922Clarissa Infant Ncpap CannulaAirways Ltd., Inc.2004—
+1K090935Minime Pediatric MaskSleepnet Corporation2009—
+2K102224Pixi Pediatric MaskResmed, Ltd.2010—
+3K120920Hsiner Cpap Silicone Nasal Mask Size XS/Petite Hsiner Nasal Pillow Mask Hsiner…Hsiner Company2012—
+1K250651OptiPAP Junior Flexi Tube US (OPTIPAPFUS); OptiPAP Junior Nasal Prongs XXS…Fisher & Paykel Healthcare, Ltd.2025—
+4K243225Nasal Pillow Mask - Small (NNPM-01/ Nefes S); Nasal Pillow Mask - Medium…Genadyne Biotechnologies, Inc.2024—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198110
198610
198710
198910

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200910
201010
201220
201610
202410
202510
FIG. 1 — Lineage of K032922, 1979–2025Source: 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 CBK? 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 CBK device

  1. #1 K252663 Inbentus Versatilescore 16.0 · 17 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? (5)

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
*K811409Argyle Cpap Nasal Cannula
Summary page 1
…5895 Device Product Code and CBK Panel Code: Anesthesiology Panel Predicate Devices: Argyle CPAP Nasal Cannula (K81 1409) Neotech Binasal Airway (K7920 18) Medicomp CPAP Nasal…
Sherwood Medical Co.1981—
*K792018Silicone Rubber-BI Nasopharyngeal Air
Summary page 1
…Anesthesiology Panel Predicate Devices: Argyle CPAP Nasal Cannula (K81 1409) Neotech Binasal Airway (K7920 18) Medicomp CPAP Nasal Cannula (K86 1280) Hudson Jnfant N…
Vesta, Inc.1979—
*K861280Medicomp Cpap Nasal Cannula
Summary page 1
…le CPAP Nasal Cannula (K81 1409) Neotech Binasal Airway (K7920 18) Medicomp CPAP Nasal Cannula (K86 1280) Hudson Jnfant Nasal CPAP Cannula (K87 1157) Ackrad Inf…
Medicomp, Inc.1986—
*K871157C.P.a.P. Nasal Cannula
Summary page 1
…asal Airway (K7920 18) Medicomp CPAP Nasal Cannula (K86 1280) Hudson Jnfant Nasal CPAP Cannula (K87 1157) Ackrad Infant Nasal Cannula (K895031) Device Description: The Clarissa Infant nCPAP Cann…
Hudson Oxygen Therapy Sales Co.19875
*K895031Modified Infant Nasal Cannulae Assembly
Summary page 1
…sal Cannula (K86 1280) Hudson Jnfant Nasal CPAP Cannula (K87 1157) Ackrad Infant Nasal Cannula (K895031) Device Description: The Clarissa Infant nCPAP Cannula is a soft hollow medical grade silicone coaxial pouch with protruding s…
Ackrad Laboratories1989—

What descends from it? (7)

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

NumberDeviceApplicantDecidedDescendants
K090935Minime Pediatric MaskSleepnet Corporation20095
K250651OptiPAP Junior Flexi Tube US (OPTIPAPFUS); OptiPAP Junior Nasal Prongs XXS…Fisher & Paykel Healthcare, Ltd.20250

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 5 ancestors has a recall of any class.
  • Of its descendants, K090935 (Sleepnet Corporation, 2009) has gone furthest, with 5 descendants of its own.

How does its category compare?

All CBK devices

CBK Ventilator, Continuous, Facility Use: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · CBK

4in 2025

2007: 112008: 182009: 122010: 142011: 132012: 172013: 52014: 52015: 72016: 42017: 62018: 42019: 82020: 52021: 62023: 52024: 92025: 42026 (partial year): 3
2007high 18 (2008) · low 0 (2022)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · CBK

163in 2025

2007: 142 days median2008: 115 days median2009: 122 days median2010: 150 days median2011: 192 days median2012: 207 days median2013: 277 days median2014: 439 days median2015: 266 days median2016: 323 days median2017: 280 days median2018: 183 days median2019: 435 days median2020: 176 days median2021: 267 days median2023: 309 days median2024: 203 days median2025: 163 days median2026 (partial year): 235 days median
2007high 439 (2014) · low 115 (2008)2026

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

Recalls per year · CBK

14in 2024

2007: 172008: 232009: 82010: 92011: 122012: 2, 1 Class I2013: 5, 2 Class I2014: 5, 4 Class I2015: 6, 4 Class I2016: 4, 1 Class I2017: 12018: 3, 3 Class I2019: 14, 13 Class I2020: 42021: 21, 19 Class I2022: 8, 4 Class I2023: 4, 3 Class I2024: 14, 14 Class I2026 (partial year): 15, 13 Class I
2007high 23 (2008) · low 0 (2025)2026

Class I (81 since 2007) Class II/III not classified

Adverse event reports per year · CBK

13,991in 2025

2007: 1,5312008: 1,9332009: 1,7662010: 1,7992011: 1,8772012: 5,5092013: 7,9212014: 7,6002015: 11,8762016: 16,0562017: 14,4512018: 9,8492019: 9,1002020: 11,0962021: 13,3222022: 15,9742023: 24,9282024: 20,3362025: 13,991
2007high 24,928 (2023) · low 1,531 (2007)2025

MAUDE reports naming product code CBK, 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
200711142171,531
200818115231,933
20091212281,766
20101415091,799
201113192121,877
2012172072 (1)5,509
201352775 (2)7,921
201454395 (4)7,600
201572666 (4)11,876
201643234 (1)16,056
20176280114,451
201841833 (3)9,849
2019843514 (13)9,100
20205176411,096
2021626721 (19)13,322
20220—8 (4)15,974
202353094 (3)24,928
2024920314 (14)20,336
20254163013,991
2026323515 (13)—

What is it indicated for?

The Clarissa Infant nCPAP Cannula is intended to be used for the administration of continuous positive airway pressure (CPAP) on continuously monitored neonatal and infant patients in the hospital/institutional environment.

Indications for use as stated in the FDA summary.

More from Airways Ltd., Inc.

2 FDA decisions under this applicant name. See the company

  • K951944NasalflairAirways Ltd., Inc. · 1997

Recent decisions in CBK

The CBK category page

  • K253647Evita (V800); Evita (V600)Draegerwerk AG & CO Kgaa · 2026
  • K252663Inbentus VersatileIconic Solutions by Murcia, SL · 2026
  • K251888VPAP Pediatric Face MaskHsiner Co., Ltd. · 2026
  • K232365Vivo 45 LSOconnell Regulatory Consultants, Inc. · 2025
  • K252173F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits – Size A (ONIV117A); F&P…Fisher & Paykel Healthcare, Ltd. · 2025

https://510kreport.com/device/K032922 · printed Nov 6, 2026

Cite this page

510(k) Report. “K032922: Clarissa Infant Ncpap Cannula.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032922

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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