510(k) · Cleared
ClearedCpap Humidifier (HC 200)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fisher & Paykel Electronics, Ltd. · BZD Ventilator, Non-Continuous (Respirator)
Cleared on Jul 10, 1998 as substantially equivalent to K961626 (Respironics, Inc., 1996) and 2 other predicates after a 322-day review. Its family tree reaches back 2 generations to 1995. 110 later devices descend from it.
- Decided
- Jul 10, 1998
- Review
- 322 days
- Class
- Class II
- Product code
- BZD
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K952292 (1995). 5 ancestors in all, the oldest K915460 (1993). 110 later devices descend from it, 5 citing it directly.
- Root · 2 generations backK952292 Puritan-Bennett Companion Nasal Cpap SystemPuritan Bennett Corp. · 1995
- 1 generation backK961626 Solo Cpap SystemRespironics, Inc. · 1996
- This deviceK973161 Cpap Humidifier (HC 200)Fisher & Paykel Electronics, Ltd. · 1998
- Descendant · cites it directly · 98 of its ownK040941 Cpap Humidifier, Model HC234 (and Related Accessories)Fisher & Paykel Healthcare, Ltd. · 2004
- Descendant · 2 generations on · 74 of its ownK041900 HC604 Cpap HumidifierFisher & Paykel Healthcare, Ltd. · 2004
- Descendant · 3 generations on · 33 of its ownK082605 Vpap Auto with Humidaire 3IResmed, Ltd. · 2009
- Descendant · 4 generations on · 31 of its ownK091947 S8 Aspen with H4I PlusResmed, Ltd. · 2009
- Descendant · 3 generations on · 30 of its ownK092846 Airvo Series HumidifiersFisher & Paykel Healthcare, Ltd. · 2010
Showing 5 of 110 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 110 · See all- K040941Cpap Humidifier, Model HC234 (and Related Accessories)Fisher & Paykel Healthcare, Ltd. · 2004 · cites it directly98descendants
- K041900HC604 Cpap HumidifierFisher & Paykel Healthcare, Ltd. · 2004 · 2 generations on74descendants
- K082605Vpap Auto with Humidaire 3IResmed, Ltd. · 2009 · 3 generations on33descendants
- K091947S8 Aspen with H4I PlusResmed, Ltd. · 2009 · 4 generations on31descendants
- K092846Airvo Series HumidifiersFisher & Paykel Healthcare, Ltd. · 2010 · 3 generations on30descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K952292 | Puritan-Bennett Companion Nasal Cpap System | Puritan Bennett Corp. | 1995 | — |
| −1 | K961626 | Solo Cpap System | Respironics, Inc. | 1996 | — |
| 0 (this device) | K973161 | Cpap Humidifier (HC 200) | Fisher & Paykel Electronics, Ltd. | 1998 | — |
| +1 | K040941 | Cpap Humidifier, Model HC234 (and Related Accessories) | Fisher & Paykel Healthcare, Ltd. | 2004 | — |
| +2 | K041900 | HC604 Cpap Humidifier | Fisher & Paykel Healthcare, Ltd. | 2004 | — |
| +3 | K082605 | Vpap Auto with Humidaire 3I | Resmed, Ltd. | 2009 | — |
| +4 | K091947 | S8 Aspen with H4I Plus | Resmed, Ltd. | 2009 | — |
| +3 | K092846 | Airvo Series Humidifiers | Fisher & Paykel Healthcare, Ltd. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 3 | 0 |
| 2010 | 4 | 0 |
| 2011 | 7 | 0 |
| 2012 | 8 | 0 |
| 2013 | 9 | 0 |
| 2014 | 8 | 0 |
| 2015 | 1 | 0 |
| 2016 | 5 | 0 |
| 2017 | 3 | 0 |
| 2018 | 4 | 0 |
| 2019 | 2 | 0 |
| 2020 | 5 | 0 |
| 2021 | 4 | 0 |
| 2022 | 5 | 0 |
| 2023 | 6 | 0 |
| 2024 | 12 | 0 |
| 2025 | 8 | 0 |
| 2026 | 5 | 0 |
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 K250624 myAirscore 15.7 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K961626 | Solo Cpap SystemSummary page 1…ation Name: Ventilator, Non-Continuous (Respirator) - 73 BZD Anesthesiology Devices, 21 CFR §868.5905 (Class Ii) Predicate Devices: Respironics Inc, Solo™ CPAP System, K961626 ResCare Ltd, Sullivan® Il Nasal CPAP System, K930656 Fisher & Paykel, HC100 Respiratory Humidifier, K915460 This summary of 510(… | 1996 |
| * | K930656 | Sullivan Iii Nasal Cpap SystemSummary page 1…- 73 BZD Anesthesiology Devices, 21 CFR §868.5905 (Class Ii) Predicate Devices: Respironics Inc, Solo™ CPAP System, K961626 ResCare Ltd, Sullivan® Il Nasal CPAP System, K930656 Fisher & Paykel, HC100 Respiratory Humidifier, K915460 This summary of 510(k) safety and effectiveness information is being subm… | 1994 |
| * | K915460 | Heated Respiratory Humidifier HC100Summary page 1…s Ii) Predicate Devices: Respironics Inc, Solo™ CPAP System, K961626 ResCare Ltd, Sullivan® Il Nasal CPAP System, K930656 Fisher & Paykel, HC100 Respiratory Humidifier, K915460 This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990… | 1993 |
What descends from it? (110)
See all 1105 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K040941 | Cpap Humidifier, Model HC234 (and Related Accessories) | 2004 | 98 |
| K052597 | Breathex Omega Cpap Device, Model 322 | 2005 | 7 |
| K014074 | Hoffrichter Vector, Vector Plus, Vector BI-Vevel, Vector BI-Level Plus, Scalar, Scalar… | 2003 | 2 |
| K041035 | Hoffrichter Trend 110 Cpap Device with Aquatrend Iii Cpap Humidifier Accessory for Trend | 2004 | 1 |
| K071069 | Mini Cpap Device and Humidifier Accessory | 2007 | 0 |
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?
- The line of descent spans 3 years and passes through 3 companies; a new generation was cleared every 2.0 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K040941 (Fisher & Paykel Healthcare, Ltd., 2004) has gone furthest, with 98 descendants of its own.
- 1 other device also cites its predicate K961626.
How does its category compare?
All BZD devicesBZD Ventilator, Non-Continuous (Respirator): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · BZD
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · BZD
189in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BZD
8in 2023
Class I (13 since 2007) Class II/III not classified
Adverse event reports per year · BZD
60,279in 2025
MAUDE reports naming product code BZD, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 21 | 83 | 29 | 65 |
| 2008 | 17 | 108 | 2 | 67 |
| 2009 | 23 | 90 | 1 | 147 |
| 2010 | 12 | 122 | 0 | 143 |
| 2011 | 23 | 125 | 1 | 189 |
| 2012 | 21 | 133 | 0 | 139 |
| 2013 | 23 | 127 | 0 | 82 |
| 2014 | 14 | 172 | 0 | 86 |
| 2015 | 11 | 224 | 0 | 114 |
| 2016 | 12 | 217 | 0 | 118 |
| 2017 | 5 | 221 | 0 | 148 |
| 2018 | 5 | 280 | 0 | 101 |
| 2019 | 6 | 231 | 4 (4) | 188 |
| 2020 | 6 | 137 | 0 | 126 |
| 2021 | 6 | 192 | 0 | 6,066 |
| 2022 | 4 | 253 | 0 | 90,768 |
| 2023 | 5 | 204 | 8 (7) | 27,987 |
| 2024 | 10 | 132 | 0 | 68,262 |
| 2025 | 7 | 189 | 0 | 60,279 |
| 2026 | 10 | 214 | 2 (2) | — |
What is it indicated for?
The Fisher & Paykel Healthcare HC200 CPAP Humidifier is a combined Continuous Positive Airway Pressure Blower and Heated Respiratory Humidifier (as per 73 BZD, 21 CFR §868.5905 and 73 BTT, 21 CFR §868.5450). The HC200 is used to assist with patient breathing while sleeping, for the purpose of treating Obstructive Sleep Apnea (OSA). This is by the delivery of Continuous Positive Airway Pressure (CPAP) in order to prevent airway obstruction. The addition…
Read the full statement (123 words)
The Fisher & Paykel Healthcare HC200 CPAP Humidifier is a combined Continuous Positive Airway Pressure Blower and Heated Respiratory Humidifier (as per 73 BZD, 21 CFR §868.5905 and 73 BTT, 21 CFR §868.5450).
The HC200 is used to assist with patient breathing while sleeping, for the purpose of treating Obstructive Sleep Apnea (OSA). This is by the delivery of Continuous Positive Airway Pressure (CPAP) in order to prevent airway obstruction.
The addition of heated respiratory humidification to the device (normally included as an accessory to CPAP therapy) relieves the drying and irritating effects on the patient airways which may arise from use of a CPAP system.
The HC200 is for use on adult, spontaneously breathing (non ventilator-dependent) patients and is a prescription-use device.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K973161 · printed Nov 6, 2026
Cite this page
510(k) Report. “K973161: Cpap Humidifier (HC 200).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K973161
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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