510(k) · Cleared
Recalled · 2004Transpac (R) II, Disposable Transducer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Laboratories · GWM Device, Monitoring, Intracranial Pressure
Cleared on Jul 3, 1990 after a 592-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 21 later devices descend from it. It has been recalled 4 times.
- Decided
- Jul 3, 1990
- Review
- 592 days
- Class
- Class II
- Product code
- GWM
- Recalls
- 4
- Predicates
- 0
21 later devices descend from it, 1 citing it directly.
- This deviceK884823 Transpac (R) II, Disposable TransducerAbbott Laboratories · 1990
- Descendant · cites it directly · 20 of its ownK061573 Transpac Iii Disposable Straight Pressure Transducer and KitHospira, Inc. · 2006 · Recalled
- Descendant · 2 generations on · 8 of its ownK171801 IntelliVue Patient Monitor MX100 and Multi-Measurement Module X3…Philips Medizin Systeme Boeblingen GmbH · 2017 · Recalled
- Descendant · 2 generations on · 7 of its ownK091408 Disposable Pressure TransducerShenzhen Ant Hi-Tech Industrial Co., Ltd. · 2009
- Descendant · 3 generations on · 6 of its ownK181314 IntelliVue Patient Monitor MX100, IntelliVue Multi-Measurement…Philips Medizin Systeme Boeblingen GmbH · 2018
- Descendant · 3 generations on · 6 of its ownK101518 Compass Vascular Access; Compass Lumbar PunctureMirador Biomedical, Inc. · 2010
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 21 · See all- K061573Transpac Iii Disposable Straight Pressure Transducer and KitHospira, Inc. · 2006 · cites it directly20descendants
- K171801IntelliVue Patient Monitor MX100 and Multi-Measurement Module X3; intelliVue Hemodynamic…Philips Medizin Systeme Boeblingen GmbH · 2017 · 2 generations on8descendants
- K091408Disposable Pressure TransducerShenzhen Ant Hi-Tech Industrial Co., Ltd. · 2009 · 2 generations on7descendants
- K181314IntelliVue Patient Monitor MX100, IntelliVue Multi-Measurement Module X3, IntelliVue…Philips Medizin Systeme Boeblingen GmbH · 2018 · 3 generations on6descendants
- K101518Compass Vascular Access; Compass Lumbar PunctureMirador Biomedical, Inc. · 2010 · 3 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K884823 | Transpac (R) II, Disposable Transducer | Abbott Laboratories | 1990 | — |
| +1 | K061573 | Transpac Iii Disposable Straight Pressure Transducer and Kit | Hospira, Inc. | 2006 | 193 |
| +2 | K171801 | IntelliVue Patient Monitor MX100 and Multi-Measurement Module X3; intelliVue… | Philips Medizin Systeme Boeblingen GmbH | 2017 | 4 |
| +2 | K091408 | Disposable Pressure Transducer | Shenzhen Ant Hi-Tech Industrial Co., Ltd. | 2009 | — |
| +3 | K181314 | IntelliVue Patient Monitor MX100, IntelliVue Multi-Measurement Module X3… | Philips Medizin Systeme Boeblingen GmbH | 2018 | — |
| +3 | K101518 | Compass Vascular Access; Compass Lumbar Puncture | Mirador Biomedical, Inc. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 3 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2023 | 2 | 0 |
| 2025 | 2 | 0 |
| 2026 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GWM? 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 GWM device
- #1 K252241 Pressio 3 Multi-parameter Neuromonitoring Systemscore 12.9 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (21)
See all 211 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K061573 | Transpac Iii Disposable Straight Pressure Transducer and Kit | 2006 | 20 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 2, 2004 | Not classified | Z-0618-05 | Other | Syringes could possibly allow air to enter the patient's vascular system. |
| Nov 2, 2004 | Not classified | Z-0619-05 | Other | Syringes could possibly allow air to enter the patient's vascular system. |
| Nov 2, 2004 | Not classified | Z-0620-05 | Other | Syringes could possibly allow air to enter the patient's vascular system. |
| Nov 2, 2004 | Not classified | Z-0617-05 | Other | Syringes could possibly allow air to enter the patient's vascular system. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K061573 (Hospira, Inc., 2006) has gone furthest, with 20 descendants of its own.
How does its category compare?
All GWM devicesGWM Device, Monitoring, Intracranial Pressure: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GWM
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GWM
30in 2020
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GWM
3in 2025
Class I (3 since 2007) Class II/III not classified
Adverse event reports per year · GWM
441in 2025
MAUDE reports naming product code GWM, 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 | 126 |
| 2008 | 2 | — | 1 | 105 |
| 2009 | 1 | — | 0 | 117 |
| 2010 | 2 | — | 9 | 104 |
| 2011 | 3 | 123 | 6 | 184 |
| 2012 | 4 | 100 | 1 | 151 |
| 2013 | 2 | — | 12 | 120 |
| 2014 | 2 | — | 2 | 360 |
| 2015 | 0 | — | 0 | 486 |
| 2016 | 3 | 192 | 0 | 419 |
| 2017 | 3 | 37 | 0 | 445 |
| 2018 | 1 | — | 0 | 302 |
| 2019 | 2 | — | 1 | 260 |
| 2020 | 3 | 30 | 0 | 268 |
| 2021 | 2 | — | 0 | 211 |
| 2022 | 0 | — | 0 | 424 |
| 2023 | 0 | — | 1 (1) | 744 |
| 2024 | 2 | — | 4 (2) | 641 |
| 2025 | 1 | — | 3 | 441 |
| 2026 | 1 | — | 0 | — |
https://510kreport.com/device/K884823 · printed Nov 6, 2026
Cite this page
510(k) Report. “K884823: Transpac (R) II, Disposable Transducer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K884823
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026