510(k) · Cleared
ClearedAllPEP
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Enchant Tek Co., Ltd. · BWF Spirometer, Therapeutic (Incentive)
Cleared on Feb 2, 2024 as substantially equivalent to K991561 (Dhd Healthcare Corp., 1999) after a 59-day review. Its family tree reaches back 3 generations to 1996.
- Decided
- Feb 2, 2024
- Review
- 59 days
- Class
- Class II
- Product code
- BWF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K954492 (1996). 7 ancestors in all, the oldest K940986 (1994). No later device cites it as a predicate yet.
- Root · 3 generations backK954492 Mercury Medical Expiratory Resistance Exerciser, ResistexMercury Medical · 1996
- 2 generations backK983467 TherapepDhd Healthcare Corp. · 1999
- 1 generation backK991561 Roadrunner, Pep Therapy DeviceDhd Healthcare Corp. · 1999
- This deviceK233855 AllPEPEnchant Tek Co., Ltd. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K954492 | Mercury Medical Expiratory Resistance Exerciser, Resistex | Mercury Medical | 1996 | — |
| −2 | K983467 | Therapep | Dhd Healthcare Corp. | 1999 | — |
| −1 | K991561 | Roadrunner, Pep Therapy Device | Dhd Healthcare Corp. | 1999 | — |
| 0 (this device) | K233855 | AllPEP | Enchant Tek Co., Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 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 |
|---|---|---|---|
| * | K991561 | Roadrunner, Pep Therapy DeviceSummary page 5…, therapeutic (incentive) 21CFR 868.5690 Product Code: BWF Predicate Device: DHD Acapella K991561 Common/Usual Name: Spirometer, therapeutic (incentive) Classification Name: 21CFR 868.5690 Prod… | 1999 |
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 28 years and passes through 3 companies; a new generation was cleared every 2.4 years on median.
- 1 of the 7 ancestors has a recall of any class.
- 3 other devices also cite its predicate K991561.
How does its category compare?
All BWF devicesBWF Spirometer, Therapeutic (Incentive): FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
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?
The Enchant AllPEP is intended for use as a Positive Expiratory Pressure (PEP) by patients aged 18 years and older. Patients must be capable of generating an exhalation flow of 10 lpm for 3-4 seconds to promote secretion clearance. This device may be used to prevent or reverse atelectasis and as an inspiratory, deep breathing positive exerciser. It may be used in hospital and clinical settings.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K233855 · printed Nov 6, 2026
Cite this page
510(k) Report. “K233855: AllPEP.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K233855
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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