510(k) Report

510(k) · Cleared

Cleared

Medsafe System Inserter

K032848510(k) TraditionalCleared Apr 12, 2004213-day reviewClass II21 CFR 880.6920

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

Medsolve Technologies, LLC · KZH Introducer, Syringe Needle

Cleared on Apr 12, 2004 as substantially equivalent to K872233 (Palco Laboratories, Inc., 1987) after a 213-day review. Its family tree reaches back 1 generation to 1987.

Decided
Apr 12, 2004
Review
213 days
Class
Class II
Product code
KZH
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K872233 (1987). No later device cites it as a predicate yet.

K872233 · Inject-Ease · Palco Laboratories, Inc. · 198719851990199520002005
K872233 · Inject-Ease · Palco Laboratories, Inc. · 19870
  1. Root · 1 generation backK872233 Inject-EasePalco Laboratories, Inc. · 1987
  2. This deviceK032848 Medsafe System InserterMedsolve Technologies, LLC · 2004
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K872233Inject-EasePalco Laboratories, Inc.1987—
0 (this device)K032848Medsafe System InserterMedsolve Technologies, LLC2004—
FIG. 1 — Lineage of K032848, 1987–2004Source: 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 KZH? 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 KZH device

  1. #1 K243232 GripMatescore 9.3 · 4 generations · no Class I recall
  2. #2 Held for the reportin the report
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What was it cleared against? (1)

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
*K872233Inject-Ease
Summary page 3
…unger. The device is disposed of in appropriate sharps containers according to local, state, and Federal regulations. Predicate Device: Palco Inject-Ease, 510K Number: K872233 Intended Use of the New Device: Single-use non-sterile device intended to aid in the insertion of a commercially available syri…
Palco Laboratories, Inc.1987—

Also cleared against K872233: 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?

  • Its one ancestor has no recall.
  • 1 other device also cites its predicate K872233.

How does its category compare?

All KZH devices

KZH Introducer, Syringe Needle: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KZH

1in 2024

2007: 12008: 22012: 22013: 12014: 12016: 12017: 12022: 12024: 1
2007high 2 (2008) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KZH

Too few KZH 510(k)s in any year since 2007 to give a median.

Recalls per year · KZH

2in 2019

2011: 12019: 2
2007high 2 (2019) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · KZH

16in 2025

2007: 22010: 32011: 202012: 202013: 532014: 1382015: 992016: 682017: 882018: 882019: 952020: 1582021: 872022: 582023: 352024: 272025: 16
2007high 158 (2020) · low 0 (2008)2025

MAUDE reports naming product code KZH, 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
20071—02
20082—00
20090—00
20100—03
20110—120
20122—020
20131—053
20141—0138
20150—099
20161—068
20171—088
20180—088
20190—295
20200—0158
20210—087
20221—058
20230—035
20241—027
20250—016
20260—0—

What is it indicated for?

Single-use non-sterile device intended to aid in the insertion of a commercially available syringe. The Safety feature prevents needle reuse.

Indications for use as stated in the FDA summary.

Also cleared against K872233

1 other device cites the same predicate.

  • K011951EZ SyringeOwen Mumford, Ltd. · 2001

Recent decisions in KZH

The KZH category page

  • K243232GripMateSynthon Hispania S.L. · 2024
  • K213429AccuSert Needle InserterEmed Technologies Corporation · 2022
  • K163400Orbit InserterYpsomed AG · 2017
  • K160860MiniMed Quick-serterMedtronic Minimed · 2016
  • K141384Whisperject AutoinjectorScandinavian Health Limited · 2014

https://510kreport.com/device/K032848 · printed Nov 6, 2026

Cite this page

510(k) Report. “K032848: Medsafe System Inserter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032848

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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