510(k) · Cleared
ClearedBreathe Easy, Models AD and CD
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Respiraid, Ltd. · FRF Cleaner, Air, Medical Recirculating
Cleared on Oct 13, 1998 as substantially equivalent to K872359 (Enviracaire Corp., 1987) after a 140-day review. Its family tree reaches back 1 generation to 1987. 10 later devices descend from it.
- Decided
- Oct 13, 1998
- Review
- 140 days
- Class
- Class II
- Product code
- FRF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K872359 (1987). 10 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK872359 Enviracaire Model EV-1Enviracaire Corp. · 1987
- This deviceK981841 Breathe Easy, Models AD and CDRespiraid, Ltd. · 1998
- Descendant · cites it directly · 7 of its ownK042610 DR. Theiss Alergol Pollen Blocker CreamDr. Theiss Naturwaren GmbH · 2005
- Descendant · 2 generations on · 6 of its ownK053625 NasalguardTrutek Corp · 2006
- Descendant · 3 generations on · 3 of its ownK132520 Nasal Ease Allergy BlockerHi-Tech Pharmacal, Inc. · 2013
- Descendant · 4 generations on · 1 of its ownK170848 Alzair Allergy BlockerNasaleze International, Ltd. · 2017
- Descendant · 2 generations on · 1 of its ownK120894 HaymaxHaymax Limited · 2012
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K042610DR. Theiss Alergol Pollen Blocker CreamDr. Theiss Naturwaren GmbH · 2005 · cites it directly7descendants
- K053625NasalguardTrutek Corp · 2006 · 2 generations on6descendants
- K132520Nasal Ease Allergy BlockerHi-Tech Pharmacal, Inc. · 2013 · 3 generations on3descendants
- K170848Alzair Allergy BlockerNasaleze International, Ltd. · 2017 · 4 generations on1descendant
- K120894HaymaxHaymax Limited · 2012 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K872359 | Enviracaire Model EV-1 | Enviracaire Corp. | 1987 | — |
| 0 (this device) | K981841 | Breathe Easy, Models AD and CD | Respiraid, Ltd. | 1998 | — |
| +1 | K042610 | DR. Theiss Alergol Pollen Blocker Cream | Dr. Theiss Naturwaren GmbH | 2005 | — |
| +2 | K053625 | Nasalguard | Trutek Corp | 2006 | — |
| +3 | K132520 | Nasal Ease Allergy Blocker | Hi-Tech Pharmacal, Inc. | 2013 | — |
| +4 | K170848 | Alzair Allergy Blocker | Nasaleze International, Ltd. | 2017 | — |
| +2 | K120894 | Haymax | Haymax Limited | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 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 FRF? 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 FRF device
- #1 K200321 Novaerus NV1050score 9.9 · 2 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 |
|---|---|---|---|
| * | K872359 | Enviracaire Model EV-1Summary page 2…egulation no. 880.5045) and it is reviewed by General Hospital Devices. k(‘i@\‘a'tl( O’L/'Z__ Predicate Device: e Enviracaire EV-1 (Enviracaire, Co.) - K872359 Indication for Use: The BREATHE EASY device is a medical recirculating air cleaner designed to remove airborne particles and al… | 1987 |
What descends from it? (10)
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?
- Its one ancestor has no recall.
- Of its descendants, K042610 (Dr. Theiss Naturwaren GmbH, 2005) has gone furthest, with 7 descendants of its own.
How does its category compare?
All FRF devicesFRF Cleaner, Air, Medical Recirculating: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FRF
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FRF
163in 2022
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FRF
1in 2012
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FRF
3in 2013
MAUDE reports naming product code FRF, 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 | 2 |
| 2008 | 2 | — | 0 | 3 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 1 | 3 |
| 2013 | 2 | — | 0 | 3 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 3 | 163 | 0 | 0 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 2 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The BREATHE EASY device is a medical recirculating air cleaner designed to remove airborne particles and allergens, such as: dust, smoke, pollen, mold spores, animal hair and dander, dust mites, and harmful fibers, that may lead to allergic reactions.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K981841 · printed Nov 4, 2026
Cite this page
510(k) Report. “K981841: Breathe Easy, Models AD and CD.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K981841
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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