510(k) · Cleared
ClearedBig Bag 3000 Pressure Infusor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Byron Medical · FRN Pump, Infusion
Cleared on Sep 12, 1997 as substantially equivalent to K800560 (Medex, Inc., 1980) and 3 other predicates after a 22-day review. Its family tree reaches back 1 generation to 1980. 5 later devices descend from it.
- Decided
- Sep 12, 1997
- Review
- 22 days
- Class
- Class II
- Product code
- FRN
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 1 generation to K800560 (1980). 4 ancestors in all. 5 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK800560 MX820-5 Pressure Infusor 500CC MX820-10Medex, Inc. · 1980
- This deviceK973133 Big Bag 3000 Pressure InfusorByron Medical · 1997
- Descendant · cites it directly · 2 of its ownK980738 Psi-Tec Syringe Infusion Pump and Accessories for General Fluid…Byron Medical · 1998
- Descendant · 2 generations on · 1 of its ownK153599 Concert Medical Hands-Free Syringe (HFS)Concert Medical, LLC · 2016
- Descendant · cites it directly · 1 of its ownK980089 3600 Presure Infusor, Sigmacon 3600, Lapro Flow 3000Valley West, Inc. · 1998
- Descendant · 3 generations on · 0 of its ownK230083 SafiraMedovate Limited · 2023
- Descendant · cites it directly · 0 of its ownK990447 1000 Pressure Infusion Sigmacon 1000Valley West, Inc. · 1999
Most influential descendants
Showing 5 of 5 · See all- K980738Psi-Tec Syringe Infusion Pump and Accessories for General Fluid Irrigaion/InfiltrationByron Medical · 1998 · cites it directly2descendants
- K153599Concert Medical Hands-Free Syringe (HFS)Concert Medical, LLC · 2016 · 2 generations on1descendant
- K9800893600 Presure Infusor, Sigmacon 3600, Lapro Flow 3000Valley West, Inc. · 1998 · cites it directly1descendant
- K230083SafiraMedovate Limited · 2023 · 3 generations on0descendants
- K9904471000 Pressure Infusion Sigmacon 1000Valley West, Inc. · 1999 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K800560 | MX820-5 Pressure Infusor 500CC MX820-10 | Medex, Inc. | 1980 | — |
| 0 (this device) | K973133 | Big Bag 3000 Pressure Infusor | Byron Medical | 1997 | — |
| +1 | K980738 | Psi-Tec Syringe Infusion Pump and Accessories for General Fluid… | Byron Medical | 1998 | — |
| +2 | K153599 | Concert Medical Hands-Free Syringe (HFS) | Concert Medical, LLC | 2016 | — |
| +1 | K980089 | 3600 Presure Infusor, Sigmacon 3600, Lapro Flow 3000 | Valley West, Inc. | 1998 | — |
| +3 | K230083 | Safira | Medovate Limited | 2023 | — |
| +1 | K990447 | 1000 Pressure Infusion Sigmacon 1000 | Valley West, Inc. | 1999 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2016 | 1 | 0 |
| 2023 | 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 FRN? 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 FRN device
- #1 K253703 RemunityPRO+ Pump for Remodulin®…score 12.6 · 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? (4)
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 |
|---|---|---|---|
| * | K800560 | MX820-5 Pressure Infusor 500CC MX820-10Summary page 2…valent to pre-amendment devices as outlined below. Product: MX820-5 Pressure Infusor 500cc / MX 820-10 Pressure Infusor 1000cc Manufacturer: Medex, Inc. 510(k) Number: K800560 Substantial Equivalence Date: 29 April 1980 Product: Nezhat-Dorsey Hydro-Dissection Universal Bag Squeezer Manufacturer: Davol,… | 1980 |
| * | K953574 | Nezhat-Dorsey Hydro-Dissection Universal Bag SqueezerSummary page 2…(k) Number: K800560 Substantial Equivalence Date: 29 April 1980 Product: Nezhat-Dorsey Hydro-Dissection Universal Bag Squeezer Manufacturer: Davol, Inc. 510(k) Number: K953574 Substantial Equivalence Date: 29 September 1995 Product: Automatic Surgical Irrigation Pump/Autocuff Manufacturer: Alton Dean Me… | 1995 |
| * | K822286 | Autocuff (Photos Enclosed with 510K Our OCR of the scanned summary read K922286, FDA’s number for Model XCT-900 PQCT X-Ray Bone Densitometer (Norland Corp.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Automatic Surgical Irrigation Pump/Autocuff”. | 1982 |
| * | K924530 | Cabot Medical Niagara (TM) 3.0 Liter High Flow IrriSummary page 2…med, inc. 510(k) Number: K922286 Substantial Equivalence Date: Unknown Product: Niagara Pump, 3.0 Liter High Volume Manufacturer: Cabot Medical Systems 510(k) Number: K924530 Substantial Equivalence Date: 05 February 1993 -end of summary- SERVICEg a UJ:, %, %, ) C DEPARTMENT OF HEALT… | 1993 |
What descends from it? (5)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
How does its category compare?
All FRN devicesFRN Pump, Infusion: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FRN
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FRN
172in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FRN
7in 2025
Class I (37 since 2007) Class II/III not classified
Adverse event reports per year · FRN
52,792in 2025
MAUDE reports naming product code FRN, 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 | 12 | 102 | 15 | 1,086 |
| 2008 | 8 | 89 | 24 | 8,261 |
| 2009 | 9 | 66 | 102 | 1,952 |
| 2010 | 3 | 93 | 37 | 6,133 |
| 2011 | 3 | 103 | 69 | 41,367 |
| 2012 | 4 | 217 | 42 (2) | 15,482 |
| 2013 | 6 | 312 | 22 (3) | 40,082 |
| 2014 | 6 | 172 | 4 (3) | 94,180 |
| 2015 | 3 | 232 | 5 | 26,742 |
| 2016 | 3 | 301 | 7 (1) | 16,560 |
| 2017 | 3 | 305 | 13 | 12,060 |
| 2018 | 3 | 267 | 1 | 16,591 |
| 2019 | 2 | — | 18 (1) | 15,850 |
| 2020 | 1 | — | 16 (5) | 94,186 |
| 2021 | 2 | — | 3 (2) | 199,342 |
| 2022 | 6 | 268 | 2 | 888,020 |
| 2023 | 7 | 265 | 16 (10) | 165,838 |
| 2024 | 5 | 103 | 9 (4) | 57,730 |
| 2025 | 8 | 172 | 7 (4) | 52,792 |
| 2026 | 2 | — | 11 (2) | — |
What is it indicated for?
The Big Bag 3000 Pressure Infusor indications for use are general surgical fluid irrigation and infiltration.
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/K973133 · printed Nov 4, 2026
Cite this page
510(k) Report. “K973133: Big Bag 3000 Pressure Infusor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K973133
Report an extraction error
Are you the manufacturer?
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