510(k) · Cleared
ClearedSurgical Patient Warmer, Model PW820 Jhu
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fisher & Paykel Healthcare, Ltd. · ILY Lamp, Infrared, Therapeutic Heating
Cleared on Mar 6, 2003 as substantially equivalent to K982636 (Fisher & Paykel Healthcare, Ltd., 1998) after a 212-day review. Its family tree reaches back 2 generations to 1987. 295 later devices descend from it.
- Decided
- Mar 6, 2003
- Review
- 212 days
- Class
- Class II
- Product code
- ILY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K871179 (1987). 4 ancestors in all. 295 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK871179 Opn Xii ULAragona AB Co. · 1987
- 1 generation backK982636 Patient Warmer- Model PW810Fisher & Paykel Healthcare, Ltd. · 1998
- This deviceK022609 Surgical Patient Warmer, Model PW820 JhuFisher & Paykel Healthcare, Ltd. · 2003
- Descendant · cites it directly · 294 of its ownK033768 Altus Medical Optional Infrared HandpieceAltus Medical, Inc. · 2004
- Descendant · 2 generations on · 241 of its ownK042165 Cutera Tabletop Aesthetic ProductCutera, Inc. · 2004 · Recalled
- Descendant · 2 generations on · 239 of its ownK050370 Palomar Luxir HandpiecePalomar Medical Technologies, Inc. · 2005
- Descendant · 2 generations on · 184 of its ownK080318 Alma Laser Nir ModuleAlma Lasers, Ltd. · 2008
- Descendant · 3 generations on · 129 of its ownK070388 Profile Multi-Platform SystemSciton, Inc · 2007
Showing 5 of 295 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 295 · See all- K033768Altus Medical Optional Infrared HandpieceAltus Medical, Inc. · 2004 · cites it directly294descendants
- K042165Cutera Tabletop Aesthetic ProductCutera, Inc. · 2004 · 2 generations on241descendants
- K050370Palomar Luxir HandpiecePalomar Medical Technologies, Inc. · 2005 · 2 generations on239descendants
- K080318Alma Laser Nir ModuleAlma Lasers, Ltd. · 2008 · 2 generations on184descendants
- K070388Profile Multi-Platform SystemSciton, Inc · 2007 · 3 generations on129descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K871179 | Opn Xii UL | Aragona AB Co. | 1987 | — |
| −1 | K982636 | Patient Warmer- Model PW810 | Fisher & Paykel Healthcare, Ltd. | 1998 | — |
| 0 (this device) | K022609 | Surgical Patient Warmer, Model PW820 Jhu | Fisher & Paykel Healthcare, Ltd. | 2003 | — |
| +1 | K033768 | Altus Medical Optional Infrared Handpiece | Altus Medical, Inc. | 2004 | — |
| +2 | K042165 | Cutera Tabletop Aesthetic Product | Cutera, Inc. | 2004 | 1 |
| +2 | K050370 | Palomar Luxir Handpiece | Palomar Medical Technologies, Inc. | 2005 | — |
| +2 | K080318 | Alma Laser Nir Module | Alma Lasers, Ltd. | 2008 | — |
| +3 | K070388 | Profile Multi-Platform System | Sciton, Inc | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 2 | 0 |
| 2005 | 4 | 0 |
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
| 2008 | 8 | 0 |
| 2009 | 3 | 0 |
| 2010 | 4 | 0 |
| 2011 | 5 | 0 |
| 2012 | 3 | 0 |
| 2013 | 4 | 0 |
| 2014 | 7 | 0 |
| 2015 | 12 | 0 |
| 2016 | 15 | 0 |
| 2017 | 11 | 0 |
| 2018 | 16 | 0 |
| 2019 | 15 | 0 |
| 2020 | 25 | 0 |
| 2021 | 22 | 0 |
| 2022 | 30 | 0 |
| 2023 | 21 | 0 |
| 2024 | 29 | 0 |
| 2025 | 36 | 0 |
| 2026 | 19 | 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 ILY? 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 ILY device
- #1 K242755 Medical Diode Laser Systems (VELAS II-30B…score 18.7 · 22 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K982636 | Patient Warmer- Model PW810Summary page 1…Infrared Lamp - 89 ILY Physical Medicine Devices, 21 CFR 5890.5500 (Class II) Predicate Device: Fisher & Paykel Healthcare PW810 Patient Warmer, K982636 Classification Name: Infrared Lamp - 89 ILY Physical Medicine Devices, 21 CFR §890.5500 (Class II) [a)(?) -… | 1998 |
What descends from it? (295)
See all 2951 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K033768 | Altus Medical Optional Infrared Handpiece | 2004 | 294 |
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 16 years and passes through 2 companies; a new generation was cleared every 11.5 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K033768 (Altus Medical, Inc., 2004) has gone furthest, with 294 descendants of its own.
- 1 other device also cites its predicate K982636.
How does its category compare?
All ILY devicesILY Lamp, Infrared, Therapeutic Heating: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · ILY
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ILY
116in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ILY
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ILY
17in 2025
MAUDE reports naming product code ILY, 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 | 10 | 128 | 0 | 24 |
| 2008 | 16 | 165 | 0 | 20 |
| 2009 | 13 | 189 | 0 | 9 |
| 2010 | 8 | 185 | 1 | 7 |
| 2011 | 9 | 198 | 0 | 10 |
| 2012 | 11 | 130 | 3 | 7 |
| 2013 | 9 | 211 | 0 | 8 |
| 2014 | 11 | 153 | 0 | 0 |
| 2015 | 11 | 146 | 0 | 2 |
| 2016 | 8 | 214 | 0 | 2 |
| 2017 | 5 | 116 | 0 | 12 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 7 |
| 2020 | 1 | — | 0 | 5 |
| 2021 | 0 | — | 0 | 5 |
| 2022 | 2 | — | 4 | 2 |
| 2023 | 1 | — | 1 | 15 |
| 2024 | 1 | — | 0 | 19 |
| 2025 | 1 | — | 1 | 17 |
| 2026 | 1 | — | 1 | — |
What is it indicated for?
The Fisher & Paykel Healthcare PW820 Surgical Patient Warmer is an Infra-red lamp. It emits energy at infra-red frequencies to provide topical heating. The PW820 is intended primarily for use in the operating room in order to alleviate patient body-core cooling induced by the use of anesthetic drugs and the operating room environment. Additionally, the PW820 may also be used to provide topical heating in other clinical situations where unobstructive…
Read the full statement (137 words)
The Fisher & Paykel Healthcare PW820 Surgical Patient Warmer is an Infra-red lamp. It emits energy at infra-red frequencies to provide topical heating. The PW820 is intended primarily for use in the operating room in order to alleviate patient body-core cooling induced by the use of anesthetic drugs and the operating room environment. Additionally, the PW820 may also be used to provide topical heating in other clinical situations where unobstructive external thermal support for patients is required (for example, post-operative recovery, hypothermia recovery, ICU).
The PW820 is operated at a fixed skin surface temperature setting of either 41°C or 37°C. The setting of 41°C is intended for adult patients under general anesthetic. The setting of 37°C is intended for pediatric and infant patients and for non-anesthetised adults.
The PW820 is for use with infants only during surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022609 · printed Nov 6, 2026
Cite this page
510(k) Report. “K022609: Surgical Patient Warmer, Model PW820 Jhu.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022609
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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