510(k) · Cleared
ClearedHsiner Resuscitator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hsiner Co., Ltd. · BTM Ventilator, Emergency, Manual (Resuscitator)
Cleared on Mar 22, 2006 as substantially equivalent to K002846 (Headstar Medical Products Co., Ltd., 2001) and 5 other predicates after a 99-day review. Its family tree reaches back 2 generations to 1993. 1 of the 8 devices in its family, counting itself, has a Class I recall.
- Decided
- Mar 22, 2006
- Review
- 99 days
- Class
- Class II
- Product code
- BTM
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 2 generations to K923976 (1993). 7 ancestors in all, the oldest K902062 (1990). No later device cites it as a predicate yet. 1 of the 8 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK923976 Ambu Single Patient Use Peep ValveAmbu, Inc. · 1993
- 1 generation backK983920 Ems Peep Valves- AdjustableEngineered Medical Systems · 1999
- This deviceK053466 Hsiner ResuscitatorHsiner Co., Ltd. · 2006
Class I recalls in this family
- K012842 V*Care Manual Resuscitatordirect predicate · 2001
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K923976 | Ambu Single Patient Use Peep Valve | Ambu, Inc. | 1993 | — |
| −1 | K983920 | Ems Peep Valves- Adjustable | Engineered Medical Systems | 1999 | — |
| 0 (this device) | K053466 | Hsiner Resuscitator | Hsiner Co., Ltd. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 2001 | 2 | 1 |
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.
1 device in this family has a Class I recall. 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? (6)
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 1…e Class 2 6.3. Substantially equivalent to: Resuscitator: a Headstar Medical Products Manual Emergency Resuscitator (1(002846), * Ventlab Corporation V*Care Manual Resuscitator (KO 12842) * Hudson RCI Lifesaver Si… | 2001 |
| * | K012842 | V*Care Manual Resuscitator | 2001 |
| * | K944301 | Hudson Rci Lifesaver Single Patient Use Manual Resuscitator Catalog Numbers: 5360…Summary page 1…46), * Ventlab Corporation V*Care Manual Resuscitator (KO 12842) * Hudson RCI Lifesaver Single Patient Use Manual Resuscitator (K 944301) PEEP Valve: * Ambu Single Patient Use PEEP Valve (K923976). * Hudson… | 1994 |
| * | K923976 | Ambu Single Patient Use Peep ValveSummary page 1…* Hudson RCI Lifesaver Single Patient Use Manual Resuscitator (K 944301) PEEP Valve: * Ambu Single Patient Use PEEP Valve (K923976). * Hudson RCI Lifesaver Peep Valve (1(902062) * Engineered Medical Systems PEEP Valve… | 1993 |
| * | K902062 | Peep ValveSummary page 1…r (K 944301) PEEP Valve: * Ambu Single Patient Use PEEP Valve (K923976). * Hudson RCI Lifesaver Peep Valve (1(902062) * Engineered Medical Systems PEEP Valve (K983920) (Revised 02/21/2006)… | 1990 |
| * | K983920 | Ems Peep Valves- AdjustableSummary page 1…Single Patient Use PEEP Valve (K923976). * Hudson RCI Lifesaver Peep Valve (1(902062) * Engineered Medical Systems PEEP Valve (K983920) (Revised 02/21/2006) page 88… | 1999 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K012842V*Care Manual ResuscitatorVentlab Corp. · 2001 · Direct predicate · ◆ in the 2001 ancestors bar of FIG. 112 Class I recalls
What does this lineage say?
- The line of descent spans 13 years and passes through 3 companies; a new generation was cleared every 7.2 years on median.
- 1 of the 7 ancestors has a recall of any class; 1 has a Class I 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?
The Hsiner PEEP Valve is used in conjunction vith manual resuscitators and other ventilatory support equipment to provide positive end expiratory pressure.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053466 · printed Nov 6, 2026
Cite this page
510(k) Report. “K053466: Hsiner Resuscitator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K053466
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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