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 3, 2002 as substantially equivalent to K982652 (Allegiance Healthcare Corp., 1999) and 1 other predicate after a 90-day review. Its family tree reaches back 2 generations to 1997. 1 later device descends from it.
- Decided
- Sep 3, 2002
- Review
- 90 days
- Class
- Class I
- Product code
- IMD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K970399 (1997). 5 ancestors in all, the oldest K934631 (1994). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK970399 Kwik Kold Peri Cold Pack (Catalog Number TBD)Allegiance Healthcare Corp. · 1997
- 1 generation backK973770 Allegiance Kwik Heat Warm Perineal PackAllegiance Healthcare Corp. · 1997
- This deviceK021843 Eyefeel Ophthalmic WarmerBio-Lipid, Inc. · 2002
- Descendant · cites it directly · 0 of its ownK082087 Eyefeel Ophthalmic WarmerBio-Lipid, Inc. · 2008
Most influential descendants
Showing 1 of 1 · See all- K082087Eyefeel Ophthalmic WarmerBio-Lipid, Inc. · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K970399 | Kwik Kold Peri Cold Pack (Catalog Number TBD) | Allegiance Healthcare Corp. | 1997 | — |
| −1 | K973770 | Allegiance Kwik Heat Warm Perineal Pack | Allegiance Healthcare Corp. | 1997 | — |
| 0 (this device) | K021843 | Eyefeel Ophthalmic Warmer | Bio-Lipid, Inc. | 2002 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 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? (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 |
|---|---|---|---|
| * | K982652 | Allegiance Porta-Warm MattressSummary page 1…Name: Hot or Cold Disposable Pack (see 21 C.F.R. § 890.5710) Product Code: IMD Predicate Devices: Porta-WarmTMMattress, 5lO(k) # K982652 Kwik HeatTMPerineal Warm Pack, 510(k) # K973770 Device Description: The EyeFeel Ophthalmic Warme… | 1999 |
| * | K973770 | Allegiance Kwik Heat Warm Perineal PackSummary page 1…Product Code: IMD Predicate Devices: Porta-WarmTMMattress, 5lO(k) # K982652 Kwik HeatTMPerineal Warm Pack, 510(k) # K973770 Device Description: The EyeFeel Ophthalmic Warmer is a simple device for application of heat the… | 1997 |
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 |
|---|---|---|---|
| K082087 | Eyefeel Ophthalmic Warmer | 2008 | 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 5 years and passes through 2 companies; a new generation was cleared every 4.8 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K082087 (Bio-Lipid, Inc., 2008) has gone furthest, with 0 descendants of its own.
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.
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 EyeFeelTM Ophthalmic warmer is a hot disposable pack for the application of localized heat therapy in cases of chronic inflammatory and cystic conditions of the eye lids, including rneibornian gland dysfunction (MGD), also known as evaporative dry eye or lipid deficiency dry eye, and chalazia.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021843 · printed Nov 4, 2026
Cite this page
510(k) Report. “K021843: 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/K021843
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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