510(k) Report

510(k) · Cleared

Cleared

Whisperflow Oxygen Flow Generator - Adjustable Model WF 8500 Whisperflow Oxygen Flow Generator - Fixed Model WF 8530 WH

K982283510(k) TraditionalCleared Mar 9, 1999252-day reviewClass II21 CFR 868.5965

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

Caradyne, Ltd. · BYE Attachment, Breathing, Positive End Expiratory Pressure

Cleared on Mar 9, 1999 as substantially equivalent to K811393 (Vital Signs, Inc., 1981) and 3 other predicates after a 252-day review. Its family tree reaches back 1 generation to 1980. 1 of the 19 devices in its family, counting itself, has a Class I recall. 14 later devices descend from it.

Decided
Mar 9, 1999
Review
252 days
Class
Class II
Product code
BYE
Recalls
None
Predicates
4

Its longest line of descent runs back 1 generation to K801883 (1980). 4 ancestors in all. 14 later devices descend from it, 4 citing it directly. 1 of the 19 devices in this family, counting this one, has a Class I recall.

Other ancestors, by year clearedDescendants, by year cleared 1987: 1 other ancestor1983: 1 other ancestor1981: 1 other ancestor2003: 2 descendants cleared2008: 2 descendants cleared2009: 2 descendants cleared2013: 3 descendants cleared, 1 with a Class I recall12011: 3 descendants cleared2010: 1 descendant cleared2014: 1 descendant clearedK801883 · Peep Face Mask · Vital Signs, Inc. · 198019801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors 1 generation forward: 4 descendants2 generations forward: 6 descendants, 1 with a Class I recall13 generations forward: 3 descendants4 generations forward: 1 descendant K801883 · Peep Face Mask · Vital Signs, Inc. · 19800
  1. Root · 1 generation backK801883 Peep Face MaskVital Signs, Inc. · 1980
  2. This deviceK982283 Whisperflow Oxygen Flow Generator - Adjustable Model WF 8500…Caradyne, Ltd. · 1999
  3. Descendant · cites it directly · 7 of its ownK080692 Macs Cpap SystemAiron Corporation · 2008
  4. Descendant · 2 generations on · 4 of its ownK092085 Ispira Resuscitation UnitNeoforce Group, Inc. · 2009
  5. Descendant · cites it directly · 4 of its ownK013884 Boussignac C.P.a.P. DeviceVygon SA · 2003
  6. Descendant · 3 generations on · 2 of its ownK102649 Neopop Infant Resuscitator with Flow MeterNeoforce Group, Inc. · 2011
  7. Descendant · cites it directly · 2 of its ownK080256 Pulmodyne CHF Flow Generator SystemPulmodyne · 2008

Showing 5 of 14 descendants. See all descendants

Descendants cleared per year

2003: 22008: 22009: 22010: 12011: 32013: 32014: 1
2003high 3 (2011) · low 0 (2004)2026

Class I recalls in this family

  • K123957 Pneupac Parapac Plus2 generations on · 2013

Most influential descendants

Showing 5 of 14 · See all
  • K080692Macs Cpap SystemAiron Corporation · 2008 · cites it directly7descendants
  • K092085Ispira Resuscitation UnitNeoforce Group, Inc. · 2009 · 2 generations on4descendants
  • K013884Boussignac C.P.a.P. DeviceVygon SA · 2003 · cites it directly4descendants
  • K102649Neopop Infant Resuscitator with Flow MeterNeoforce Group, Inc. · 2011 · 3 generations on2descendants
  • K080256Pulmodyne CHF Flow Generator SystemPulmodyne · 2008 · cites it directly2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K801883Peep Face MaskVital Signs, Inc.1980—
0 (this device)K982283Whisperflow Oxygen Flow Generator - Adjustable Model WF 8500 Whisperflow…Caradyne, Ltd.1999—
+1K080692Macs Cpap SystemAiron Corporation2008—
+2K092085Ispira Resuscitation UnitNeoforce Group, Inc.2009—
+1K013884Boussignac C.P.a.P. DeviceVygon SA2003—
+3K102649Neopop Infant Resuscitator with Flow MeterNeoforce Group, Inc.2011—
+1K080256Pulmodyne CHF Flow Generator SystemPulmodyne2008—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198110
198310
198710

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200320
200820
200920
201010
201130
201331
201410
FIG. 1 — Lineage of K982283, 1980–2014Source: 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.

1 device in this family has 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
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
*K811393Downs Cap Flow Generator
Summary page 1
…ator Classification Name: Breathing Attachment, Positive End Expiratory Pressure Whisperflow Oxygen Flow Generators and accessories Vital Signs - Downs Flow Generators - K811393, K831503 Vital Signs CPAP mask - K801883 EMS Mask - K871851 Device: Predicate Devices: escription: The Whisperflow Oxygen Fl…
Vital Signs, Inc.1981—
*K831503Downs Adjustable Flow Generator
Summary page 1
…sification Name: Breathing Attachment, Positive End Expiratory Pressure Whisperflow Oxygen Flow Generators and accessories Vital Signs - Downs Flow Generators - K811393, K831503 Vital Signs CPAP mask - K801883 EMS Mask - K871851 Device: Predicate Devices: escription: The Whisperflow Oxygen Flow Genera…
Vital Signs, Inc.1983—
*K801883Peep Face Mask
Summary page 1
…hment, Positive End Expiratory Pressure Whisperflow Oxygen Flow Generators and accessories Vital Signs - Downs Flow Generators - K811393, K831503 Vital Signs CPAP mask - K801883 EMS Mask - K871851 Device: Predicate Devices: escription: The Whisperflow Oxygen Flow Generator is a venturi type oxygen / a…
Vital Signs, Inc.1980—
*K871851Ribbed Cushion Mask
Summary page 1
…Expiratory Pressure Whisperflow Oxygen Flow Generators and accessories Vital Signs - Downs Flow Generators - K811393, K831503 Vital Signs CPAP mask - K801883 EMS Mask - K871851 Device: Predicate Devices: escription: The Whisperflow Oxygen Flow Generator is a venturi type oxygen / air mixture delivery…
Engineered Medical Systems1987—

What descends from it? (14)

See all 14

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

NumberDeviceApplicantDecidedDescendants
K080692Macs Cpap SystemAiron Corporation20087
K013884Boussignac C.P.a.P. DeviceVygon SA20034
K080256Pulmodyne CHF Flow Generator SystemPulmodyne20082
K023683Multi-Strap Full Face MaskEngineered Medical Systems20030

Has anything in its family been recalled? (1 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.

  • K123957Pneupac Parapac PlusSmiths Medical International, Ltd. · 2013 · 2 generations on · ◆ in the 2013 descendants bar of FIG. 16 Class I recalls

What does this lineage say?

  • None of the 4 ancestors has a recall.
  • Of its descendants, K080692 (Airon Corporation, 2008) has gone furthest, with 7 descendants of its own.

How does its category compare?

All BYE devices

BYE Attachment, Breathing, Positive End Expiratory Pressure: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · BYE

1in 2016

2007: 12008: 12009: 32010: 12011: 32013: 12014: 22016: 1
2007high 3 (2009) · low 0 (2012)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · BYE

117in 2011

2009: 155 days median2011: 117 days median
2007high 155 (2009) · low 117 (2011)2026

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

Recalls per year · BYE

1in 2015

2007: 42008: 22015: 12026 (partial year): 1, 1 Class I
2007high 4 (2007) · low 0 (2009)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · BYE

7in 2025

2007: 82008: 32009: 12010: 42011: 22012: 62013: 22014: 82015: 42017: 32018: 112019: 52020: 52021: 42022: 102023: 82024: 92025: 7
2007high 11 (2018) · low 0 (2016)2025

MAUDE reports naming product code BYE, 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
20071—48
20081—23
2009315501
20101—04
2011311702
20120—06
20131—02
20142—08
20150—14
20161—00
20170—03
20180—011
20190—05
20200—05
20210—04
20220—010
20230—08
20240—09
20250—07
20260—1 (1)—

What is it indicated for?

To provide CPAP to spontaneously breathing patients in the hospital and pre-hospital (EMS) environment.

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

More from Caradyne, Ltd.

5 FDA decisions under this applicant name. See the company

  • K040862Guardian Neonate Cpap/Humidification SystemCaradyne, Ltd. · 20042 recalls
  • K023565OxicheckCaradyne, Ltd. · 2003
  • K000959Criterion 60 or PM 60Caradyne, Ltd. · 2000
  • K992101Criterion 40 or PM 40Caradyne, Ltd. · 2000

Recent decisions in BYE

The BYE category page

  • K160112Besmed PEEP ValveBesmed Health Business Corp · 2016
  • K133957Disposable Adjustable Peep Valve MR Conditional UseGalemed Corp. · 2014
  • K133210B&B BubblerS & T Medical Technologies, Inc. · 2014
  • K122610Plaxtron Cpap System, Model CH-FFM-87XX/CH-FFM-88XX SeriesSen MU Technology Co., Ltd. · 2013
  • K112546O_Two Cpap SystemO-Two Medical Technologies, Inc. · 2011

https://510kreport.com/device/K982283 · printed Nov 6, 2026

Cite this page

510(k) Report. “K982283: Whisperflow Oxygen Flow Generator - Adjustable Model WF 8500 Whisperflow Oxygen Flow Generator - Fixed Model WF 8530 WH.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K982283

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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