510(k) · Cleared
ClearedEyefeel Ophthalmic Warmer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bio-Lipid, Inc. · IMD Pack, Hot Or Cold, Disposable
Cleared on Sep 11, 2008 as substantially equivalent to K021843 (Bio-Lipid, Inc., 2002) after a 50-day review. Its family tree reaches back 3 generations to 1997.
- Decided
- Sep 11, 2008
- Review
- 50 days
- Class
- Class I
- Product code
- IMD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K970399 (1997). 6 ancestors in all, the oldest K934631 (1994). No later device cites it as a predicate yet.
- Root · 3 generations backK970399 Kwik Kold Peri Cold Pack (Catalog Number TBD)Allegiance Healthcare Corp. · 1997
- 2 generations backK973770 Allegiance Kwik Heat Warm Perineal PackAllegiance Healthcare Corp. · 1997
- 1 generation backK021843 Eyefeel Ophthalmic WarmerBio-Lipid, Inc. · 2002
- This deviceK082087 Eyefeel Ophthalmic WarmerBio-Lipid, Inc. · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K970399 | Kwik Kold Peri Cold Pack (Catalog Number TBD) | Allegiance Healthcare Corp. | 1997 | — |
| −2 | K973770 | Allegiance Kwik Heat Warm Perineal Pack | Allegiance Healthcare Corp. | 1997 | — |
| −1 | K021843 | Eyefeel Ophthalmic Warmer | Bio-Lipid, Inc. | 2002 | — |
| 0 (this device) | K082087 | Eyefeel Ophthalmic Warmer | Bio-Lipid, Inc. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1999 | 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 IMD? 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 IMD device
- #1 K221653 InfaTherm Disposable Infant Warming Mattressscore 4.4 · 2 generations · no Class I recall
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 |
|---|---|---|---|
| * | K021843 | Eyefeel Ophthalmic Warmer Our reading of the summary gave K021834, FDA’s number for Suture Fixation Device; Mesh Fixation Device (Mle, Inc.). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “EyeFeel Ophthalmic Warmer”. | 2002 |
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 11 years and passes through 2 companies; a new generation was cleared every 4.8 years on median.
- 1 of the 6 ancestors has a recall of any class.
How does its category compare?
All IMD devicesIMD Pack, Hot Or Cold, Disposable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · IMD
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · IMD
Too few IMD 510(k)s in any year since 2007 to give a median.
Recalls per year · IMD
4in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IMD
66in 2025
MAUDE reports naming product code IMD, 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 | 1 | — | 0 | 211 |
| 2008 | 1 | — | 4 | 804 |
| 2009 | 0 | — | 0 | 210 |
| 2010 | 0 | — | 1 | 58 |
| 2011 | 0 | — | 0 | 70 |
| 2012 | 1 | — | 0 | 53 |
| 2013 | 0 | — | 0 | 40 |
| 2014 | 0 | — | 0 | 33 |
| 2015 | 0 | — | 1 | 193 |
| 2016 | 0 | — | 0 | 213 |
| 2017 | 1 | — | 0 | 234 |
| 2018 | 0 | — | 3 | 262 |
| 2019 | 0 | — | 0 | 632 |
| 2020 | 0 | — | 0 | 248 |
| 2021 | 0 | — | 4 | 142 |
| 2022 | 1 | — | 0 | 202 |
| 2023 | 0 | — | 0 | 184 |
| 2024 | 0 | — | 0 | 112 |
| 2025 | 0 | — | 0 | 66 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The EyeFeel ophthalmic warmer is a hot disposable pack for the application of localized heat therapy in cases of chronic inflammatory and cystic conditions of the eyelids, including meibomian gland dysfunction (MGD), also known as evaporative dry eye or lipid deficiency dry eye, and chalazia.
The EyeFeel Ophthalmic Warmer also may relieve accommodative fatigue and may help recover baseline visual acuity levels after prolonged work on visual display terminals.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082087 · printed Nov 4, 2026
Cite this page
510(k) Report. “K082087: Eyefeel Ophthalmic Warmer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K082087
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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