510(k) · Cleared
ClearedMercury Medical Expiratory Resistance Exerciser, Resistex
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mercury Medical · BWF Spirometer, Therapeutic (Incentive)
Cleared on Oct 21, 1996 after a 390-day review. The FDA summary names its predicate without a number. 9 later devices descend from it.
- Decided
- Oct 21, 1996
- Review
- 390 days
- Class
- Class II
- Product code
- BWF
- Recalls
- None
- Predicates
- 0
9 later devices descend from it, 2 citing it directly.
- This deviceK954492 Mercury Medical Expiratory Resistance Exerciser, ResistexMercury Medical · 1996
- Descendant · cites it directly · 7 of its ownK983467 TherapepDhd Healthcare Corp. · 1999
- Descendant · 2 generations on · 5 of its ownK991561 Roadrunner, Pep Therapy DeviceDhd Healthcare Corp. · 1999
- Descendant · 3 generations on · 1 of its ownK140772 Aerosure MedicActegy, Ltd. · 2014
- Descendant · 3 generations on · 0 of its ownK233855 AllPEPEnchant Tek Co., Ltd. · 2024
- Descendant · 4 generations on · 0 of its ownK203378 PulsehalerRespinova, Ltd. · 2021
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K983467TherapepDhd Healthcare Corp. · 1999 · cites it directly7descendants
- K991561Roadrunner, Pep Therapy DeviceDhd Healthcare Corp. · 1999 · 2 generations on5descendants
- K140772Aerosure MedicActegy, Ltd. · 2014 · 3 generations on1descendant
- K233855AllPEPEnchant Tek Co., Ltd. · 2024 · 3 generations on0descendants
- K203378PulsehalerRespinova, Ltd. · 2021 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K954492 | Mercury Medical Expiratory Resistance Exerciser, Resistex | Mercury Medical | 1996 | — |
| +1 | K983467 | Therapep | Dhd Healthcare Corp. | 1999 | — |
| +2 | K991561 | Roadrunner, Pep Therapy Device | Dhd Healthcare Corp. | 1999 | — |
| +3 | K140772 | Aerosure Medic | Actegy, Ltd. | 2014 | — |
| +3 | K233855 | AllPEP | Enchant Tek Co., Ltd. | 2024 | — |
| +4 | K203378 | Pulsehaler | Respinova, Ltd. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 3 | 0 |
| 2009 | 1 | 0 |
| 2014 | 2 | 0 |
| 2016 | 1 | 0 |
| 2021 | 1 | 0 |
| 2024 | 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 BWF? 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 BWF device
- #1 K241152 InSeescore 9.9 · 1 generation · 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 |
|---|---|---|---|
| * | — | Circulaire™ Aerosol Drug Delivery System Named without a submission number |
What descends from it? (9)
2 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?
- Of its descendants, K983467 (Dhd Healthcare Corp., 1999) has gone furthest, with 7 descendants of its own.
How does its category compare?
All BWF devicesBWF Spirometer, Therapeutic (Incentive): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · BWF
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · BWF
281in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BWF
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · BWF
3in 2025
MAUDE reports naming product code BWF, 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 | 1 |
| 2008 | 0 | — | 0 | 2 |
| 2009 | 2 | — | 0 | 3 |
| 2010 | 1 | — | 0 | 5 |
| 2011 | 0 | — | 0 | 39 |
| 2012 | 0 | — | 0 | 5 |
| 2013 | 1 | — | 0 | 19 |
| 2014 | 3 | 105 | 0 | 5 |
| 2015 | 1 | — | 0 | 16 |
| 2016 | 3 | 149 | 0 | 6 |
| 2017 | 3 | 136 | 0 | 7 |
| 2018 | 1 | — | 0 | 7 |
| 2019 | 3 | 281 | 0 | 16 |
| 2020 | 1 | — | 1 | 5 |
| 2021 | 1 | — | 0 | 9 |
| 2022 | 1 | — | 0 | 8 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 11 |
| 2025 | 1 | — | 0 | 3 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
PERMITS RESISTANCE BREATHING DURING AEROSOL TREATMENT
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/K954492 · printed Nov 4, 2026
Cite this page
510(k) Report. “K954492: Mercury Medical Expiratory Resistance Exerciser, Resistex.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K954492
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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