510(k) Report

510(k) · Cleared

Recalled · Class II · 2016

Freedom 60 Syringe Infusion Pump System with Syringe Set & Tubing

K933652510(k) TraditionalCleared May 18, 1994294-day reviewClass II21 CFR 880.5725Recalls 1

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

Repro-Med Systems, Inc. · FRN Pump, Infusion

Cleared on May 18, 1994 after a 294-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 15 later devices descend from it. It has been recalled once.

Decided
May 18, 1994
Review
294 days
Class
Class II
Product code
FRN
Recalls
1
Predicates
0

15 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2015: 1 descendant cleared2017: 1 descendant cleared2014: 1 descendant cleared2016: 1 descendant cleared2021: 2 descendants cleared2022: 2 descendants cleared2018: 1 descendant cleared2024: 2 descendants cleared2023: 2 descendants cleared2026: 1 descendant cleared2025: 1 descendant cleared1990200020102020
  1. This deviceK933652 Freedom 60 Syringe Infusion Pump System with Syringe Set & TubingRepro-Med Systems, Inc. · 1994
  2. Descendant · cites it directly · 7 of its ownK140133 Infuset Flow Control Extension SetEmed Technologies Corporation · 2014
  3. Descendant · cites it directly · 6 of its ownK162613 Integrated Catch-up Freedom Syringe Driver Infusion SystemRepro-Med Systems, Inc. Dba Rms Medical Products · 2017
  4. Descendant · cites it directly · 6 of its ownK142319 SCIg60 Infuser, InfusetEmed Technologies Corporation · 2015
  5. Descendant · 2 generations on · 5 of its ownK161906 SCIg60 InfuserEmed Technologies Corporation · 2016
  6. Descendant · 3 generations on · 3 of its ownK222087 SCIg60 Infusion SystemEmed Technologies Corporation · 2022

Showing 5 of 15 descendants. See all descendants

Descendants cleared per year

2014: 12015: 12016: 12017: 12018: 12021: 22022: 22023: 22024: 22025: 12026: 1
2014high 2 (2021) · low 0 (2019)2026

Most influential descendants

Showing 5 of 15 · See all
  • K140133Infuset Flow Control Extension SetEmed Technologies Corporation · 2014 · cites it directly7descendants
  • K162613Integrated Catch-up Freedom Syringe Driver Infusion SystemRepro-Med Systems, Inc. Dba Rms Medical Products · 2017 · cites it directly6descendants
  • K142319SCIg60 Infuser, InfusetEmed Technologies Corporation · 2015 · cites it directly6descendants
  • K161906SCIg60 InfuserEmed Technologies Corporation · 2016 · 2 generations on5descendants
  • K222087SCIg60 Infusion SystemEmed Technologies Corporation · 2022 · 3 generations on3descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K933652Freedom 60 Syringe Infusion Pump System with Syringe Set & TubingRepro-Med Systems, Inc.1994—
+1K140133Infuset Flow Control Extension SetEmed Technologies Corporation2014—
+1K162613Integrated Catch-up Freedom Syringe Driver Infusion SystemRepro-Med Systems, Inc. Dba Rms Medical Products2017—
+1K142319SCIg60 Infuser, InfusetEmed Technologies Corporation2015—
+2K161906SCIg60 InfuserEmed Technologies Corporation2016—
+3K222087SCIg60 Infusion SystemEmed Technologies Corporation2022—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201410
201510
201610
201710
201810
202120
202220
202320
202420
202510
202610
FIG. 1 — Lineage of K933652, 1994–2026Source: 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), 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (15)

See all 15

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K140133Infuset Flow Control Extension SetEmed Technologies Corporation20147
K162613Integrated Catch-up Freedom Syringe Driver Infusion SystemRepro-Med Systems, Inc. Dba Rms Medical Products20176
K142319SCIg60 Infuser, InfusetEmed Technologies Corporation20156

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

Recalls of this device

DateClassRecallRoot causeReason
Mar 10, 2016Class IIZ-0317-2018Nonconforming Material/ComponentOn 2/24/2016 during post sterilization inspection of part number F180 Precision Flow Rate Tubing, Lot number 1.042/16 the firm found 701 out of 3,195 were rejected due to visual defect, gap in the supplier s manufacturing seal for Part…

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K140133 (Emed Technologies Corporation, 2014) has gone furthest, with 7 descendants of its own.

How does its category compare?

All FRN devices

FRN Pump, Infusion: FDA decisions, review times, recalls and adverse event reports over 20 years.

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)—

More from Repro-Med Systems, Inc.

12 FDA decisions under this applicant name. See the company

  • K102512RMS Subcutaneous Needle SetRepro-Med Systems, Inc. · 2011
  • K981506Restore Vacuum Erection Device, Confide Vacuum Erection Device, Pep (Penile Erection Program), Rely Vacuum…Repro-Med Systems, Inc. · 1998
  • P820034/S005Repro-Med - THDRepro-Med Systems, Inc. · 1997
  • P820034/S004Repro-Med - THDRepro-Med Systems, Inc. · 1993
  • P820034/S003Repro-Med - THD Address Change / Manu. FacilityRepro-Med Systems, Inc. · 1993

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/K933652 · printed Nov 6, 2026

Cite this page

510(k) Report. “K933652: Freedom 60 Syringe Infusion Pump System with Syringe Set & Tubing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K933652

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026