510(k) · Cleared
ClearedAG Mass
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hospitech Respiration, Ltd. · JCX Apparatus, Suction, Ward Use, Portable, Ac-Powered
Cleared on May 13, 2013 as substantially equivalent to K060277 (Boehringer Laboratories, 2006) and 2 other predicates after a 24-day review. Its family tree reaches back 4 generations to 1994.
- Decided
- May 13, 2013
- Review
- 24 days
- Class
- Class II
- Product code
- JCX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K935218 (1994). 9 ancestors in all, the oldest K821481 (1982). No later device cites it as a predicate yet.
- Root · 4 generations backK935218 Schuco-Vac Model 178Schuco, Inc. · 1994
- 3 generations backK982304 Devilbiss Suction UnitSunrise Medical Hhg, Inc. · 1998 · Recalled
- 2 generations backK063448 Emg AC/DC Suction UnitEmg Technology Co., Ltd. · 2006
- 1 generation backK082762 Aardvark Nasal Irrigation and Aspiration DeviceAardvark Medical · 2008
- This deviceK131099 AG MassHospitech Respiration, Ltd. · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K935218 | Schuco-Vac Model 178 | Schuco, Inc. | 1994 | — |
| −3 | K982304 | Devilbiss Suction Unit | Sunrise Medical Hhg, Inc. | 1998 | 3 |
| −2 | K063448 | Emg AC/DC Suction Unit | Emg Technology Co., Ltd. | 2006 | — |
| −1 | K082762 | Aardvark Nasal Irrigation and Aspiration Device | Aardvark Medical | 2008 | — |
| 0 (this device) | K131099 | AG Mass | Hospitech Respiration, Ltd. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2006 | 1 | 0 |
| 2011 | 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 JCX? 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 JCX device
- #1 K250964 Protable Phlegm Suction Unit (JMA D01)score 12.2 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K060277 | Boehringer Laboratories Suction Pump SystemSummary page 2…g predicate devices is claimed: Device Name Manufacturer 510k No Date of approval Boehirnger Laboratories Boehirnger K060277 March 03, 2006 Suction Pump System Laboratories Aardvark nasal irrigation Aardvark K082762… | 2006 |
| * | K082762 | Aardvark Nasal Irrigation and Aspiration DeviceSummary page 2…Laboratories Boehirnger K060277 March 03, 2006 Suction Pump System Laboratories Aardvark nasal irrigation Aardvark K082762 Nov. 12 2008 and aspiration device Medical ___________ Single Cannula Extended… | 2008 |
| * | K102563 | Single Cannula Extended ApplicatorSummary page 2…K082762 Nov. 12 2008 and aspiration device Medical ___________ Single Cannula Extended Micromedics, K102563 March 15, 2011 Applicator Inc. Performance Standards AG MASSM was te… | 2011 |
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 19 years and passes through 5 companies; a new generation was cleared every 4.5 years on median.
- 1 of the 9 ancestors has a recall of any class.
- 2 other devices also cite its predicate K060277.
How does its category compare?
All JCX devicesJCX Apparatus, Suction, Ward Use, Portable, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · JCX
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JCX
30in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JCX
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JCX
45in 2025
MAUDE reports naming product code JCX, 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 | 0 | — | 0 | 48 |
| 2008 | 4 | 43 | 3 | 57 |
| 2009 | 1 | — | 0 | 34 |
| 2010 | 1 | — | 0 | 7 |
| 2011 | 2 | — | 2 | 9 |
| 2012 | 2 | — | 0 | 18 |
| 2013 | 5 | 144 | 2 | 12 |
| 2014 | 4 | 106 | 0 | 68 |
| 2015 | 0 | — | 0 | 118 |
| 2016 | 2 | — | 0 | 119 |
| 2017 | 2 | — | 1 | 102 |
| 2018 | 2 | — | 0 | 170 |
| 2019 | 3 | 30 | 0 | 132 |
| 2020 | 0 | — | 1 | 89 |
| 2021 | 0 | — | 0 | 227 |
| 2022 | 1 | — | 0 | 215 |
| 2023 | 1 | — | 0 | 187 |
| 2024 | 1 | — | 0 | 103 |
| 2025 | 2 | — | 0 | 45 |
| 2026 | 1 | — | 1 | — |
What is it indicated for?
The AG MASS Suction Pump System is intended for the application of low flow suction for the removal of fluids, including irrigation fluids, body fluids and infectious materials.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131099 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131099: AG Mass.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131099
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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