510(k) Report

510(k) · Cleared

Cleared

Solace Post-Operative Pain Relief Infusion System

K060933510(k) TraditionalCleared May 9, 200634-day reviewClass II21 CFR 880.5725

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

Apex Medical Technologies, Inc. · MEB Pump, Infusion, Elastomeric

Cleared on May 9, 2006 as substantially equivalent to K051253 (Baxter Healthcare Corp, 2005) and 5 other predicates after a 34-day review. Its family tree reaches back 5 generations to 1981.

Decided
May 9, 2006
Review
34 days
Class
Class II
Product code
MEB
Recalls
None
Predicates
6

Its longest line of descent runs back 5 generations to K813186 (1981). 19 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2005: 1 other ancestor2004: 1 other ancestor2000: 2 other ancestors1999: 1 other ancestor1998: 4 other ancestors2001: 1 other ancestor1995: 1 other ancestor1990: 1 other ancestor1993: 1 other ancestor1984: 1 other ancestorK813186 · Perfix Set for Epidural Anesthesia W/Tuo · Burron Medical Products, Inc. · 1981K991543 · Intraop Catheter · I-Flow Corp. · 1999K994374 · Soaker Catheter · I-Flow Corp. · 2000K022869 · Soaker Catheter · I-Flow Corp. · 2002K043456 · Modification to Soaker Catheter · I-Flow Corp. · 2005198019851990199520002005
Other ancestors, by generation 1 generation back: 5 other ancestors2 generations back: 6 other ancestors3 generations back: 3 other ancestors K043456 · Modification to Soaker Catheter · I-Flow Corp. · 2005K022869 · Soaker Catheter · I-Flow Corp. · 2002K994374 · Soaker Catheter · I-Flow Corp. · 2000K991543 · Intraop Catheter · I-Flow Corp. · 1999K813186 · Perfix Set for Epidural Anesthesia W/Tuo · Burron Medical Products, Inc. · 1981−50
  1. Root · 5 generations backK813186 Perfix Set for Epidural Anesthesia W/TuoBurron Medical Products, Inc. · 1981
  2. 4 generations backK991543 Intraop CatheterI-Flow Corp. · 1999
  3. 3 generations backK994374 Soaker CatheterI-Flow Corp. · 2000
  4. 2 generations backK022869 Soaker CatheterI-Flow Corp. · 2002
  5. 1 generation backK043456 Modification to Soaker CatheterI-Flow Corp. · 2005
  6. This deviceK060933 Solace Post-Operative Pain Relief Infusion SystemApex Medical Technologies, Inc. · 2006
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K813186Perfix Set for Epidural Anesthesia W/TuoBurron Medical Products, Inc.1981—
−4K991543Intraop CatheterI-Flow Corp.1999—
−3K994374Soaker CatheterI-Flow Corp.2000—
−2K022869Soaker CatheterI-Flow Corp.2002—
−1K043456Modification to Soaker CatheterI-Flow Corp.2005—
0 (this device)K060933Solace Post-Operative Pain Relief Infusion SystemApex Medical Technologies, Inc.2006—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198410
199010
199310
199510
199840
199910
200020
200110
200410
200510
FIG. 1 — Lineage of K060933, 1981–2006Source: 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 MEB? 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 MEB device

  1. #1 K250234 SMARTeZ™ Elastomeric Infusion Pump (RS series)score 14.5 · 12 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against? (6)

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
*K051253Modification to: Multirate Infusor SV )with and Without PCM), Multirate Infusor LV (with…Baxter Healthcare Corp20052
*K040337I-Flow Elastomeric Pump (on-Q, Painbuster, C-Bloc, Homepump)
Summary page 1
…Pump, Infusion, Elastomeric (21CFR 880.5725, Product Code MEB, MRZ) Comparison Device: Baxter Infusor, K0S 1253 I-Flow Pump, K040337 Baxter Pain Management System, K002380 I-Flow PainBuster Infusion Kit, K982946…
I-Flow Corp.2004—
*K002380Infusor SV, Infusor LV, Baxter Pain Management System
Summary page 1
…MEB, MRZ) Comparison Device: Baxter Infusor, K0S 1253 I-Flow Pump, K040337 Baxter Pain Management System, K002380 I-Flow PainBuster Infusion Kit, K982946 I-Flow Nerve Block Infusion Kit, K984502…
Baxter Healthcare Corp2000—
*K982946Painbuster Infusion Kit
Summary page 1
…er Infusor, K0S 1253 I-Flow Pump, K040337 Baxter Pain Management System, K002380 I-Flow PainBuster Infusion Kit, K982946 I-Flow Nerve Block Infusion Kit, K984502 I-Flow Soaker Catheter, K043456 Device Descripti…
I-Flow Corp.1998—
*K984502Nerve Block Infusion Kit
Summary page 1
…Baxter Pain Management System, K002380 I-Flow PainBuster Infusion Kit, K982946 I-Flow Nerve Block Infusion Kit, K984502 I-Flow Soaker Catheter, K043456 Device Description: Apex's Solace Post-Operative Pain Relief Infusion Sys…
I-Flow Corp.1999—
*K043456Modification to Soaker Catheter
Summary page 1
…K002380 I-Flow PainBuster Infusion Kit, K982946 I-Flow Nerve Block Infusion Kit, K984502 I-Flow Soaker Catheter, K043456 Device Description: Apex's Solace Post-Operative Pain Relief Infusion System is a single use infusion…
I-Flow Corp.2005—

Also cleared against K051253: 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)

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 25 years and passes through 3 companies; a new generation was cleared every 2.3 years on median.
  • 4 of the 19 ancestors have a recall of any class.
  • 1 other device also cites its predicate K051253.

How does its category compare?

All MEB devices

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

FDA decisions per year · MEB

2in 2024

2007: 52008: 22009: 12013: 12014: 12016: 12019: 12024: 22026 (partial year): 1
2007high 5 (2007) · low 0 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MEB

42in 2007

2007: 42 days median
2007high 42 (2007)2026

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

Recalls per year · MEB

17in 2018

2007: 12008: 32009: 482010: 22011: 8, 1 Class I2013: 2, 1 Class I2018: 17
2007high 48 (2009) · low 0 (2012)2026

Class I (2 since 2007) Class II/III not classified

Adverse event reports per year · MEB

1,408in 2025

2007: 1102008: 4442009: 7982010: 1,8272011: 2,2652012: 1,9762013: 1,9562014: 2,6952015: 2,9802016: 2,1472017: 1,6532018: 1,4732019: 9742020: 2,7322021: 1,8022022: 1,2882023: 1,2482024: 1,4242025: 1,408
2007high 2,980 (2015) · low 110 (2007)2025

MAUDE reports naming product code MEB, 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
20075421110
20082—3444
20091—48798
20100—21,827
20110—8 (1)2,265
20120—01,976
20131—2 (1)1,956
20141—02,695
20150—02,980
20161—02,147
20170—01,653
20180—171,473
20191—0974
20200—02,732
20210—01,802
20220—01,288
20230—01,248
20242—01,424
20250—01,408
20261—0—

What is it indicated for?

The Solace Infusion System is intended for continuous infusion of medications directly into the intraoperative site for post-operative pain management. Additional routes of administration include subcutaneous and intramuscular infusion.

Indications for use as stated in the FDA summary.

Also cleared against K051253

1 other device cites the same predicate.

  • K131247Multibolus II Disposable Pain Management SystemMfs - Medical Flow Systems, Ltd. · 2013

More from Apex Medical Technologies, Inc.

8 FDA decisions under this applicant name. See the company

  • K112165Rhea CupApex Medical Technologies, Inc. · 2012
  • K954791Seminal Fluid Collection Kit IIApex Medical Technologies, Inc. · 1996
  • K922688Extra Protection Polyurethane CondomApex Medical Technologies, Inc. · 1995
  • K930313Apex Specimen BagApex Medical Technologies, Inc. · 1993
  • K902936Polyurethane CondomApex Medical Technologies, Inc. · 1991

Recent decisions in MEB

The MEB category page

  • K250234SMARTeZ™ Elastomeric Infusion Pump (RS series)Epic Medical Pte., Ltd. · 2026
  • K240624InfuLifeFirst Medical Source, LLC · 2024
  • K242152SMARTeZ™ Elastomeric Infusion Pump (498111, 498121, 498131, 498141)Epic Medical Pte., Ltd. · 2024
  • K181360ON-Q* Pump with BolusHalyard Health · 2019
  • K151650SMARTez elastomeric infusion pumpEpic Medical Pte., Ltd. · 2016

https://510kreport.com/device/K060933 · printed Nov 4, 2026

Cite this page

510(k) Report. “K060933: Solace Post-Operative Pain Relief Infusion System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060933

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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