510(k) · Cleared
ClearedBashan TDP Heat Lamp
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Chogqing Yuhe Medical Instruments Co., Ltd. · ILY Lamp, Infrared, Therapeutic Heating
Cleared on Feb 14, 2017 as substantially equivalent to K081720 (Prime Herbs Corporation, 2009) and 1 other predicate after a 151-day review. Its family tree reaches back 2 generations to 2001.
- Decided
- Feb 14, 2017
- Review
- 151 days
- Class
- Class II
- Product code
- ILY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K003538 (2001). 6 ancestors in all, the oldest K890556 (1989). No later device cites it as a predicate yet.
- 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 deviceK162590 Bashan TDP Heat LampChogqing Yuhe Medical Instruments Co., Ltd. · 2017
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) | K162590 | Bashan TDP Heat Lamp | Chogqing Yuhe Medical Instruments Co., Ltd. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2009 | 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? (2)
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 |
|---|---|---|---|
| * | K081720 | Precision TDP, Heat and Infrared Lamps and Marvel and Wonder LampsSummary page 5…166F File No.: 510(k) Submission Report (V1.0), Chapter 5 - 510(k) Summary 3. Predicate Device Information: Predicate Device 1: 510(K) Number: K081720 Company Name: Prime Herbs Corporation Trade Name: Precision TDP Lamp, Precision Heat Lamp, Precision Infrared Lamp, Marvel Lamp,… | 2009 |
| * | K043558 | Xinfeng Heat Lamps, Models, CQ-27,CQ-36, CQ-55, CQ-55ASummary page 5…DP Lamp, Precision Heat Lamp, Precision Infrared Lamp, Marvel Lamp, Wonder Lamp Common Name: Infrared Heating Lamp Product Code: ILY Predicate Device 2: 510(K) Number: K043558 Company Name: Chongqing Xinfeng Medical Instrument Co., Ltd. Trade Name: Xinfeng Lamp Common Name: Infrared Heating Lamp Product… | 2005 |
What descends from it?
No later submission names this one as a predicate yet.
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 3 companies; a new generation was cleared every 11.7 years on median.
- None of the 6 ancestors has a recall.
How does its category compare?
All ILY devicesILY Lamp, Infrared, Therapeutic Heating: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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?
Bashan TDP Heat Lamp is used for the temporary relief of minor muscle and joint pain and stiffness, the temporary relief of minor joint pain associated with arthritis, the temporary increase in local circulation where applied, and the relaxation of muscles. In addition, it may also help muscle spasms, minor sprains and strains, and minor muscular back pain.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162590 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162590: Bashan TDP Heat Lamp.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162590
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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