510(k) Report

510(k) · Cleared

Cleared

Silberg T.P.S., Tissue Preparation System, Model ME 800

K023083510(k) AbbreviatedCleared Feb 28, 2003164-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

Mettler Electronics Corp. · FRN Pump, Infusion

Cleared on Feb 28, 2003 as substantially equivalent to K934846 (Mettler Electronics Corp., 1994) and 1 other predicate after a 164-day review. Its family tree reaches back 1 generation to 1994.

Decided
Feb 28, 2003
Review
164 days
Class
Class II
Product code
FRN
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K934846 (1994). 2 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1999: 1 other ancestorK934846 · Sonicator 716 · Mettler Electronics Corp. · 19941990199520002005
Other ancestors, by generation 1 generation back: 1 other ancestor K934846 · Sonicator 716 · Mettler Electronics Corp. · 19940
  1. Root · 1 generation backK934846 Sonicator 716Mettler Electronics Corp. · 1994
  2. This deviceK023083 Silberg T.P.S., Tissue Preparation System, Model ME 800Mettler Electronics Corp. · 2003
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K934846Sonicator 716Mettler Electronics Corp.1994—
0 (this device)K023083Silberg T.P.S., Tissue Preparation System, Model ME 800Mettler Electronics Corp.2003—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199910
FIG. 1 — Lineage of K023083, 1994–2003Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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? (2)

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
*K934846Sonicator 716
Summary page 1
…Ultrasonic Physiotherapy Predicate Devices: TRADENAME: 5 1O(k) Number Sonicator 716, Model ME 716 K934846 Irrigation or Infkion Pump “K” Pump K991203 Description of Proposed Device: The Silberg Tissue Preparati…
Mettler Electronics Corp.1994—
*K991203Irrigation or Infusion Pump K Pump
Summary page 1
…ME: 5 1O(k) Number Sonicator 716, Model ME 716 K934846 Irrigation or Infkion Pump “K” Pump K991203 Description of Proposed Device: The Silberg Tissue Preparation System, Model ME 800, consists of a 1 MHz ultrasonic…
Kmi Kolster Methods, Inc.1999—

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?

  • None of the 2 ancestors has a recall.

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)—

What is it indicated for?

The one megahertr ultrasoundlperistaltic imgation pump combination system, bade name Silberg T.P.S. (Tissue Preparation System), provides a method for the subcutaneous infusion and ultrasonic dispersion of tumescent fluid. It is not indicated for the administration of parenteral fluids, infusion of drugs, or for any lifesustaining purpose.

Indications for use as stated in the FDA summary.

More from Mettler Electronics Corp.

32 FDA decisions under this applicant name. See the company

  • K113017Sys*Stim 240Mettler Electronics Corp. · 2012
  • K111482Sonicator Plus 920Mettler Electronics Corp. · 2011
  • K091540MTD 4000Mettler Electronics Corp. · 20091 recall
  • K071137Sonicator Plus 940, Model ME940Mettler Electronics Corp. · 2007
  • K053546Sonicator 740, Model ME 740Mettler Electronics Corp. · 2006

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/K023083 · printed Nov 6, 2026

Cite this page

510(k) Report. “K023083: Silberg T.P.S., Tissue Preparation System, Model ME 800.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023083

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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