510(k) · Cleared
ClearedShineball PVC Manual Resusciator, Ent-1001, Ent-1003, Ent-1005, Shineball Silicone Manual Resusciator, Ent-1022,
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Enter Medical Corporation · BTM Ventilator, Emergency, Manual (Resuscitator)
Cleared on Mar 11, 2005 as substantially equivalent to K002846 (Headstar Medical Products Co., Ltd., 2001) after a 172-day review. Its family tree reaches back 1 generation to 2001.
- Decided
- Mar 11, 2005
- Review
- 172 days
- Class
- Class II
- Product code
- BTM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K002846 (2001). No later device cites it as a predicate yet.
- Root · 1 generation backK002846 Headstar's Manual Emergency ResuscitatorHeadstar Medical Products Co., Ltd. · 2001
- This deviceK042556 Shineball PVC Manual Resusciator, Ent-1001, Ent-1003, Ent-1005…Enter Medical Corporation · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K002846 | Headstar's Manual Emergency Resuscitator | Headstar Medical Products Co., Ltd. | 2001 | — |
| 0 (this device) | K042556 | Shineball PVC Manual Resusciator, Ent-1001, Ent-1003, Ent-1005, Shineball… | Enter Medical Corporation | 2005 | — |
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 BTM? 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 BTM device
- #1 K243861 butterflyBVMscore 9.5 · 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 |
|---|---|---|---|
| * | K002846 | Headstar's Manual Emergency ResuscitatorSummary page 2…10993-10 * Skin sensitization study- ISO 10993-10 Legally marketed device for substantial equivalence comparison: HEADSTAR Manual Resuscitator ( K002846) Conclusion: The predicate device and the new device are the same technical characteristics. There are inclu… | 2001 |
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?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K002846.
How does its category compare?
All BTM devicesBTM Ventilator, Emergency, Manual (Resuscitator): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · BTM
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · BTM
83in 2008
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BTM
9in 2024
Class I (24 since 2007) Class II/III not classified
Adverse event reports per year · BTM
36in 2025
MAUDE reports naming product code BTM, 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 | 2 | — | 0 | 65 |
| 2008 | 3 | 83 | 0 | 31 |
| 2009 | 0 | — | 23 | 21 |
| 2010 | 2 | — | 3 | 23 |
| 2011 | 2 | — | 0 | 48 |
| 2012 | 1 | — | 13 (13) | 69 |
| 2013 | 0 | — | 3 (1) | 44 |
| 2014 | 0 | — | 0 | 108 |
| 2015 | 1 | — | 0 | 36 |
| 2016 | 1 | — | 0 | 92 |
| 2017 | 0 | — | 0 | 56 |
| 2018 | 2 | — | 0 | 56 |
| 2019 | 0 | — | 0 | 46 |
| 2020 | 0 | — | 0 | 26 |
| 2021 | 1 | — | 0 | 42 |
| 2022 | 1 | — | 0 | 35 |
| 2023 | 1 | — | 9 | 46 |
| 2024 | 0 | — | 9 (9) | 33 |
| 2025 | 2 | — | 0 | 36 |
| 2026 | 1 | — | 1 (1) | — |
What is it indicated for?
To be used in emergency situations to provide lung ventilation to
individuals whose breathing is inadequate.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042556 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042556: Shineball PVC Manual Resusciator, Ent-1001, Ent-1003, Ent-1005, Shineball Silicone Manual Resusciator, Ent-1022,.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042556
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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