510(k) · Cleared
ClearedPatient Warmer- Model PW810
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 Oct 26, 1998 as substantially equivalent to K871179 (Aragona AB Co., 1987) and 2 other predicates after an 89-day review. Its family tree reaches back 1 generation to 1987. 322 later devices descend from it.
- Decided
- Oct 26, 1998
- Review
- 89 days
- Class
- Class II
- Product code
- ILY
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K871179 (1987). 3 ancestors in all. 322 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK871179 Opn Xii ULAragona AB Co. · 1987
- This deviceK982636 Patient Warmer- Model PW810Fisher & Paykel Healthcare, Ltd. · 1998
- Descendant · cites it directly · 295 of its ownK022609 Surgical Patient Warmer, Model PW820 JhuFisher & Paykel Healthcare, Ltd. · 2003
- Descendant · 2 generations on · 294 of its ownK033768 Altus Medical Optional Infrared HandpieceAltus Medical, Inc. · 2004
- Descendant · 3 generations on · 241 of its ownK042165 Cutera Tabletop Aesthetic ProductCutera, Inc. · 2004 · Recalled
- Descendant · 3 generations on · 239 of its ownK050370 Palomar Luxir HandpiecePalomar Medical Technologies, Inc. · 2005
- Descendant · 3 generations on · 184 of its ownK080318 Alma Laser Nir ModuleAlma Lasers, Ltd. · 2008
Showing 5 of 322 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 322 · See all- K022609Surgical Patient Warmer, Model PW820 JhuFisher & Paykel Healthcare, Ltd. · 2003 · cites it directly295descendants
- K033768Altus Medical Optional Infrared HandpieceAltus Medical, Inc. · 2004 · 2 generations on294descendants
- K042165Cutera Tabletop Aesthetic ProductCutera, Inc. · 2004 · 3 generations on241descendants
- K050370Palomar Luxir HandpiecePalomar Medical Technologies, Inc. · 2005 · 3 generations on239descendants
- K080318Alma Laser Nir ModuleAlma Lasers, Ltd. · 2008 · 3 generations on184descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K871179 | Opn Xii UL | Aragona AB Co. | 1987 | — |
| 0 (this device) | K982636 | Patient Warmer- Model PW810 | Fisher & Paykel Healthcare, Ltd. | 1998 | — |
| +1 | K022609 | Surgical Patient Warmer, Model PW820 Jhu | Fisher & Paykel Healthcare, Ltd. | 2003 | — |
| +2 | K033768 | Altus Medical Optional Infrared Handpiece | Altus Medical, Inc. | 2004 | — |
| +3 | K042165 | Cutera Tabletop Aesthetic Product | Cutera, Inc. | 2004 | 1 |
| +3 | K050370 | Palomar Luxir Handpiece | Palomar Medical Technologies, Inc. | 2005 | — |
| +3 | K080318 | Alma Laser Nir Module | Alma Lasers, Ltd. | 2008 | — |
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 |
|---|---|---|
| 2003 | 3 | 0 |
| 2004 | 2 | 0 |
| 2005 | 4 | 0 |
| 2006 | 2 | 0 |
| 2007 | 3 | 0 |
| 2008 | 11 | 0 |
| 2009 | 4 | 0 |
| 2010 | 6 | 0 |
| 2011 | 5 | 0 |
| 2012 | 4 | 0 |
| 2013 | 4 | 0 |
| 2014 | 8 | 0 |
| 2015 | 14 | 0 |
| 2016 | 16 | 0 |
| 2017 | 12 | 0 |
| 2018 | 17 | 0 |
| 2019 | 17 | 0 |
| 2020 | 28 | 0 |
| 2021 | 22 | 0 |
| 2022 | 31 | 0 |
| 2023 | 21 | 0 |
| 2024 | 30 | 0 |
| 2025 | 38 | 0 |
| 2026 | 20 | 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? (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 |
|---|---|---|---|
| * | K871179 | Opn Xii ULSummary page 1…rmer Classification Name: Infrared Lamp - 89 ILY Physical Medicine Devices, 21 CFR §890.5500 (Class Il) Predicate Devices: Aragona Medical, Thermal Ceiling OPN XIl UL, K871179 Aragona Medical, Mobile Thermal Ceiling MTC XI UL, K871178 Fisher & Paykel Healthcare, IW910 Infant Warmer, K970432 This summary… | 1987 |
| * | K871178 | MTC XI ULSummary page 1…Medicine Devices, 21 CFR §890.5500 (Class Il) Predicate Devices: Aragona Medical, Thermal Ceiling OPN XIl UL, K871179 Aragona Medical, Mobile Thermal Ceiling MTC XI UL, K871178 Fisher & Paykel Healthcare, IW910 Infant Warmer, K970432 This summary of 510(k) safety and effectiveness information is being su… | 1987 |
| * | K970432 | Infant Radiant Warmer - Models IW910 and IW920Summary page 1…Devices: Aragona Medical, Thermal Ceiling OPN XIl UL, K871179 Aragona Medical, Mobile Thermal Ceiling MTC XI UL, K871178 Fisher & Paykel Healthcare, IW910 Infant Warmer, K970432 This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR §80… | 1997 |
What descends from it? (322)
See all 3222 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 3 ancestors has a recall of any class.
- Of its descendants, K022609 (Fisher & Paykel Healthcare, Ltd., 2003) has gone furthest, with 295 descendants of its own.
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 PW810 Patient Warmer is an Infrared Lamp (as per 89 ILY, 21 CFR §890.5500) containing an infrared heating element to be positioned above an operating table or similar patient bed, in order to maintain a patient’s body temperature by means of controlled radiant heat. The PW810 is intended to provide topical heating to patients in clinical situations where external thermal support is required or desirable. This may include…
Read the full statement (132 words)
The Fisher & Paykel Healthcare PW810 Patient Warmer is an Infrared Lamp (as per 89 ILY, 21 CFR §890.5500) containing an infrared heating element to be positioned above an operating table or similar patient bed, in order to maintain a patient’s body temperature by means of controlled radiant heat.
The PW810 is intended to provide topical heating to patients in clinical situations where external thermal support is required or desirable. This may include during or following surgical procedures, hypothermia recovery, and severe burns patients.
Situations which necessitate unobstructed access to a patient may indicate the need for a radiant heat source, in preference to thermal regulation systems which rely on extensive surface contact with a patient. Minimal direct contact by a warming system may also be required for particular injuries to patients.
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/K982636 · printed Nov 4, 2026
Cite this page
510(k) Report. “K982636: Patient Warmer- Model PW810.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K982636
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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