510(k) · Cleared
ClearedAspr-Care Closed System,Dual Swivel Piece T,Sheathed Suction Catheter,Bronchosope Adapter,in-Line Specimen Trap
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Davis & Geck, Inc. · BTM Ventilator, Emergency, Manual (Resuscitator)
Cleared on Sep 3, 1997 as substantially equivalent to K955831 (Sherwood Medical Co., 1996) after an 89-day review. Its family tree reaches back 1 generation to 1996.
- Decided
- Sep 3, 1997
- Review
- 89 days
- Class
- Class II
- Product code
- BTM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K955831 (1996). No later device cites it as a predicate yet.
- Root · 1 generation backK955831 Argyle Aspr-Care Closed Suction SystemSherwood Medical Co. · 1996
- This deviceK972139 Aspr-Care Closed System,Dual Swivel Piece T,Sheathed Suction…Davis & Geck, Inc. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K955831 | Argyle Aspr-Care Closed Suction System | Sherwood Medical Co. | 1996 | — |
| 0 (this device) | K972139 | Aspr-Care Closed System,Dual Swivel Piece T,Sheathed Suction… | Davis & Geck, Inc. | 1997 | — |
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 |
|---|---|---|---|
| * | K955831 | Argyle Aspr-Care Closed Suction SystemSummary page 1…yle ASPR-Care Closed Suction System has been determined to be Substantially Equivalent to the Devices marketed in interstate commerce prior to May 28, 1976 under 510k, K955831. The adapter provides the trained clinician with an accessory that facilitates the manual ventilation of the patient, without req… | 1996 |
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.
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 Device allows for the connection of 2 manual resuscitation bag without the disconnection of the ventilator circuit/system or the removal of the ASPR-Care™ CSS dual swivel T-piece connector.
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/K972139 · printed Nov 6, 2026
Cite this page
510(k) Report. “K972139: Aspr-Care Closed System,Dual Swivel Piece T,Sheathed Suction Catheter,Bronchosope Adapter,in-Line Specimen Trap.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K972139
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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