510(k) · Cleared
ClearedXinfeng Heat Lamps, Models, CQ-27,CQ-36, CQ-55, CQ-55A
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Chongqing Xinfeng Medical Instruments Co., Ltd. · ILY Lamp, Infrared, Therapeutic Heating
Cleared on Jun 6, 2005 as substantially equivalent to K003538 (Lhasa Medical, Inc., 2001) after a 161-day review. Its family tree reaches back 1 generation to 2001. 4 later devices descend from it.
- Decided
- Jun 6, 2005
- Review
- 161 days
- Class
- Class II
- Product code
- ILY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K003538 (2001). 4 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK003538 TDP CQ-27 Heat LampLhasa Medical, Inc. · 2001
- This deviceK043558 Xinfeng Heat Lamps, Models, CQ-27,CQ-36, CQ-55, CQ-55AChongqing Xinfeng Medical Instruments Co., Ltd. · 2005
- Descendant · cites it directly · 1 of its ownK102149 Gaunying Infrared LampFoshan Gaunying Electronics Co., Ltd. · 2010
- Descendant · cites it directly · 0 of its ownK162590 Bashan TDP Heat LampChogqing Yuhe Medical Instruments Co., Ltd. · 2017
- Descendant · 2 generations on · 0 of its ownK110721 Gaunying Infrared LampFoshan Gaunying Electronics Co., Ltd. · 2011
- Descendant · cites it directly · 0 of its ownK101693 Gaunying Infrared Lamp Model IL50Foshan Gaunying Electronics Co., Ltd. · 2011
Most influential descendants
Showing 4 of 4 · See all- K102149Gaunying Infrared LampFoshan Gaunying Electronics Co., Ltd. · 2010 · cites it directly1descendant
- K162590Bashan TDP Heat LampChogqing Yuhe Medical Instruments Co., Ltd. · 2017 · cites it directly0descendants
- K110721Gaunying Infrared LampFoshan Gaunying Electronics Co., Ltd. · 2011 · 2 generations on0descendants
- K101693Gaunying Infrared Lamp Model IL50Foshan 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 |
|---|---|---|---|---|---|
| −1 | K003538 | TDP CQ-27 Heat Lamp | Lhasa Medical, Inc. | 2001 | — |
| 0 (this device) | K043558 | Xinfeng Heat Lamps, Models, CQ-27,CQ-36, CQ-55, CQ-55A | Chongqing Xinfeng Medical Instruments Co., Ltd. | 2005 | — |
| +1 | K102149 | Gaunying Infrared Lamp | Foshan Gaunying Electronics Co., Ltd. | 2010 | — |
| +1 | K162590 | Bashan TDP Heat Lamp | Chogqing Yuhe Medical Instruments Co., Ltd. | 2017 | — |
| +2 | K110721 | Gaunying Infrared Lamp | Foshan Gaunying Electronics Co., Ltd. | 2011 | — |
| +1 | K101693 | Gaunying Infrared Lamp Model IL50 | Foshan Gaunying Electronics Co., Ltd. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2017 | 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 |
|---|---|---|---|
| * | K003538 | TDP CQ-27 Heat LampSummary page 2…7 K043558 Additional Information for Xinfeng Heating Lamp Regulation Number: 890.5500 Product Code: ILY 510(k) Number: K003538 Registration Number: 1222811 Owner/Operator Number: 9003816 Description of the Xinfeng Heating Lamps: Xinfeng Heating Lamp… | 2001 |
What descends from it? (4)
3 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?
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?
Xinfeng Heating lamp, including CQ-27, CQ-36 and CQ-55A, is an infrared lamp that emits the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature, to temporarily increase local blood circulation, and to temporarily relieve minor muscle and joint pain and stiffness. The lamps may also help to relieve minor pain associated with muscle spasms, minor sprains and strains, and minor muscular back pain.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043558 · printed Nov 5, 2026
Cite this page
510(k) Report. “K043558: Xinfeng Heat Lamps, Models, CQ-27,CQ-36, CQ-55, CQ-55A.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K043558
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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