510(k) Report

510(k) · Cleared

Recalled · Class II · 2016

Aff (Mark I) Volumetric Infusion Pump

K070529510(k) TraditionalCleared May 8, 200774-day reviewClass II21 CFR 880.5725Recalls 5

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Definitive Medical Technologies, Ltd. · FRN Pump, Infusion

Cleared on May 8, 2007 as substantially equivalent to K003029 (B.Braun Medical, Inc., 2000) and 2 other predicates after a 74-day review. Its family tree reaches back 1 generation to 1992. It has been recalled 5 times.

Decided
May 8, 2007
Review
74 days
Class
Class II
Product code
FRN
Recalls
5
Predicates
3

Its longest line of descent runs back 1 generation to K915522 (1992). 3 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2000: 1 other ancestor1995: 1 other ancestorK915522 · Flo-Gard (R) 6201 · Baxter Healthcare Corp · 1992 · recalled1990199520002005
Other ancestors, by generation 1 generation back: 2 other ancestors K915522 · Flo-Gard (R) 6201 · Baxter Healthcare Corp · 1992 · recalled0
  1. Root · 1 generation backK915522 Flo-Gard (R) 6201Baxter Healthcare Corp · 1992 · Recalled
  2. This deviceK070529 Aff (Mark I) Volumetric Infusion PumpDefinitive Medical Technologies, Ltd. · 2007
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K915522Flo-Gard (R) 6201Baxter Healthcare Corp19926
0 (this device)K070529Aff (Mark I) Volumetric Infusion PumpDefinitive Medical Technologies, Ltd.2007—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199510
200010
FIG. 1 — Lineage of K070529, 1992–2007Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K253703 RemunityPRO+ Pump for Remodulin®…score 12.6 · 4 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K003029Infusomat P
Summary page 1
…R 880.5725- Trade-name of device: AFF (MARK I) Volumetric Infusion Pump 3. Predicate Devices: B. Braun Infusomatic Infusion Pump (K003029) Sigma International 8000 Infusion Pump (K950766) Baxter Flo-Gard Inf…
B.Braun Medical, Inc.2000—
*K950766Sigma 8000 and Sigma 8002
Summary page 1
…Infusion Pump 3. Predicate Devices: B. Braun Infusomatic Infusion Pump (K003029) Sigma International 8000 Infusion Pump (K950766) Baxter Flo-Gard Infusion Pump (K915522) 4. Description: The Definitive Medical Tech…
Sigma Intl. General Medical Apparatus, Inc.1995—
*K915522Flo-Gard (R) 6201
Summary page 1
…matic Infusion Pump (K003029) Sigma International 8000 Infusion Pump (K950766) Baxter Flo-Gard Infusion Pump (K915522) 4. Description: The Definitive Medical Technologies AFF (Mark I) Volumetric Infusion Pump…
Baxter Healthcare Corp19926

Also cleared against K003029: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Jun 14, 2016Class IIZ-2220-2016Device DesignWalkMed Infusion, LLC Announces a Voluntary Field Action of the Triton Infusion Pump (model 300000) and Triton FP Infusion Pump (model 400000) Due to Unapproved Changes to the Software and Specifications of the Triton Infusion Pump (model…
Jun 14, 2016Class IIZ-2219-2016Device DesignWalkMed Infusion, LLC Announces a Voluntary Field Action of the Triton Infusion Pump (model 300000) and Triton FP Infusion Pump (model 400000) Due to Unapproved Changes to the Software and Specifications of the Triton Infusion Pump (model…
Oct 1, 2015Class IIZ-0242-2016Device DesignThe device might fail to detect air in line while infusing the medication Venofer. This may occur when a drop of Venofer gets stuck in the tubing adjacent to the bubble detector and the Total Volume Limit is programmed higher than the…
Feb 17, 2014Class IIZ-1122-2014Labeling designWalkMed Infusion is initiaing a recall on their Triton FP Infusion Pump, Part Number 400000 due to the label on the right side of the pump containing an incorrect instruction.
Jun 17, 2010Not classifiedZ-0307-2011Device DesignPump door may be in a near shut position, but unlatched, and the "Door Open" alarm may not sound.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • 1 of the 3 ancestors has a recall of any class.
  • 1 other device also cites its predicate K003029.

How does its category compare?

All FRN devices

FRN Pump, Infusion: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · FRN

8in 2025

2007: 122008: 82009: 92010: 32011: 32012: 42013: 62014: 62015: 32016: 32017: 32018: 32019: 22020: 12021: 22022: 62023: 72024: 52025: 82026 (partial year): 2
2007high 12 (2007) · low 1 (2020)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FRN

172in 2025

2007: 102 days median2008: 89 days median2009: 66 days median2010: 93 days median2011: 103 days median2012: 217 days median2013: 312 days median2014: 172 days median2015: 232 days median2016: 301 days median2017: 305 days median2018: 267 days median2022: 268 days median2023: 265 days median2024: 103 days median2025: 172 days median
2007high 312 (2013) · low 66 (2009)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · FRN

7in 2025

2007: 152008: 242009: 1022010: 372011: 692012: 42, 2 Class I2013: 22, 3 Class I2014: 4, 3 Class I2015: 52016: 7, 1 Class I2017: 132018: 12019: 18, 1 Class I2020: 16, 5 Class I2021: 3, 2 Class I2022: 22023: 16, 10 Class I2024: 9, 4 Class I2025: 7, 4 Class I2026 (partial year): 11, 2 Class I
2007high 102 (2009) · low 1 (2018)2026

Class I (37 since 2007) Class II/III not classified

Adverse event reports per year · FRN

52,792in 2025

2007: 1,0862008: 8,2612009: 1,9522010: 6,1332011: 41,3672012: 15,4822013: 40,0822014: 94,1802015: 26,7422016: 16,5602017: 12,0602018: 16,5912019: 15,8502020: 94,1862021: 199,3422022: 888,0202023: 165,8382024: 57,7302025: 52,792
2007high 888,020 (2022) · low 1,086 (2007)2025

MAUDE reports naming product code FRN, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200712102151,086
2008889248,261
20099661021,952
2010393376,133
201131036941,367
2012421742 (2)15,482
2013631222 (3)40,082
201461724 (3)94,180
20153232526,742
201633017 (1)16,560
201733051312,060
20183267116,591
20192—18 (1)15,850
20201—16 (5)94,186
20212—3 (2)199,342
202262682888,020
2023726516 (10)165,838
202451039 (4)57,730
202581727 (4)52,792
20262—11 (2)—

What is it indicated for?

The AFF (MARK I) Volumetric Infusion Pump is indicated for delivering infusions of medications, as well as providing TPN (Total Parenteral Nutrition) and PCA (Patient Control Analgesia). It is intended for use in hospitals, ambulatory & nursing home (extended care) settings, and home care environments.

Indications for use as stated in the FDA summary.

Also cleared against K003029

1 other device cites the same predicate.

  • K100705Zyno Z-800 Infusion System Model Z-800Zyno Medical, LLC · 20105 Class I recalls

Recent decisions in FRN

The FRN category page

  • K253703RemunityPRO+ Pump for Remodulin® (treprostinil) InjectionDeka R&D Corp · 2026
  • K252015FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate TubingKoru Medical Systems, Inc. · 2026
  • K251636Spectrum IQ Infusion System with Dose IQ Safety Software (3570009)Baxter Healthcare Corporation · 20251 recall
  • K251640SIGMA Spectrum Infusion Pump with Master Drug LibraryBaxter Healthcare Corporation · 20251 recall
  • K242752MRidium 3870 MRI Infusion Pump System (3870)Iradimed Corporation · 2025

https://510kreport.com/device/K070529 · printed Nov 6, 2026

Cite this page

510(k) Report. “K070529: Aff (Mark I) Volumetric Infusion Pump.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070529

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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