510(k) · Cleared
ClearedGaunying Infrared Lamp
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Foshan Gaunying Electronics Co., Ltd. · ILY Lamp, Infrared, Therapeutic Heating
Cleared on Aug 13, 2010 as substantially equivalent to K043558 (Chongqing Xinfeng Medical Instruments Co., Ltd., 2005) after a 14-day review. Its family tree reaches back 2 generations to 2001. 1 later device descends from it.
- Decided
- Aug 13, 2010
- Review
- 14 days
- Class
- Class II
- Product code
- ILY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K003538 (2001). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK003538 TDP CQ-27 Heat LampLhasa Medical, Inc. · 2001
- 1 generation backK043558 Xinfeng Heat Lamps, Models, CQ-27,CQ-36, CQ-55, CQ-55AChongqing Xinfeng Medical Instruments Co., Ltd. · 2005
- This deviceK102149 Gaunying Infrared LampFoshan Gaunying Electronics Co., Ltd. · 2010
- Descendant · cites it directly · 0 of its ownK110721 Gaunying Infrared LampFoshan Gaunying Electronics Co., Ltd. · 2011
Most influential descendants
Showing 1 of 1 · See all- K110721Gaunying Infrared LampFoshan Gaunying Electronics Co., Ltd. · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K003538 | TDP CQ-27 Heat Lamp | Lhasa Medical, Inc. | 2001 | — |
| −1 | K043558 | Xinfeng Heat Lamps, Models, CQ-27,CQ-36, CQ-55, CQ-55A | Chongqing Xinfeng Medical Instruments Co., Ltd. | 2005 | — |
| 0 (this device) | K102149 | Gaunying Infrared Lamp | Foshan Gaunying Electronics Co., Ltd. | 2010 | — |
| +1 | K110721 | Gaunying Infrared Lamp | Foshan Gaunying Electronics Co., Ltd. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 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 |
|---|---|---|---|
| * | K043558 | Xinfeng Heat Lamps, Models, CQ-27,CQ-36, CQ-55, CQ-55ASummary page 2…Device: Xinfeng Heating Lamp, including 3 different models CQ- 27, CQ-36 and CQ-55A 510(K) Number: K043558 4.0 Device description Gaunying Infrared Lamp (Model#: FIR 51, SN-5SI) has a high-quality glass ceramic plate (cer… | 2005 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K110721 | Gaunying Infrared Lamp | 2011 | 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 9 years and passes through 3 companies; a new generation was cleared every 5.2 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K110721 (Foshan Gaunying Electronics Co., Ltd., 2011) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K043558.
How does its category compare?
All ILY devicesILY Lamp, Infrared, Therapeutic Heating: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
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 Gaunying Infrared Lamp ( Model #: FIR 51, SN-5SI) are intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, or muscle spasm; the temporary increase in local blood circulation; and / or the temporary relaxation of muscle.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102149 · printed Nov 3, 2026
Cite this page
510(k) Report. “K102149: Gaunying Infrared Lamp.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K102149
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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