510(k) · Cleared
ClearedMedsci 3% Glutaraldehyde
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medsci, Inc. · MED Sterilant, Medical Devices
Cleared on Sep 2, 1998 as substantially equivalent to K923744 (Johnson & Johnson Medical, Inc., 1994) after a 310-day review. Its family tree reaches back 1 generation to 1994.
- Decided
- Sep 2, 1998
- Review
- 310 days
- Class
- Class II
- Product code
- MED
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K923744 (1994). No later device cites it as a predicate yet.
- Root · 1 generation backK923744 Cidex Plus 28 Day SolutionJohnson & Johnson Medical, Inc. · 1994
- This deviceK974062 Medsci 3% GlutaraldehydeMedsci, Inc. · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K923744 | Cidex Plus 28 Day Solution | Johnson & Johnson Medical, Inc. | 1994 | — |
| 0 (this device) | K974062 | Medsci 3% Glutaraldehyde | Medsci, Inc. | 1998 | — |
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 MED? 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 MED device
- #1 K251666 SYSTEM 1E Liquid Chemical Sterilant Processing…score 13.8 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K923744 | Cidex Plus 28 Day SolutionSummary page 1…5 (336) 274-0149 Date Prepared: August 20, 1998 Substantial Equivalence Statement: MedSCl 3% glutaraldehyde is substantially equivalent to the predicate J&J Cidexplus (K923744). DESCRIPTION: MedSCI 3% glutaraldehyde is an activated glutaraldehyde liquid chemical sterilant and high-level disinfectant whe… | 1994 |
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.
- 2 other devices also cite its predicate K923744.
How does its category compare?
All MED devicesMED Sterilant, Medical Devices: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MED
2in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · MED
84in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MED
2in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MED
9in 2025
MAUDE reports naming product code MED, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 3 | 34 |
| 2008 | 1 | — | 2 | 79 |
| 2009 | 0 | — | 0 | 158 |
| 2010 | 6 | 281 | 0 | 89 |
| 2011 | 0 | — | 2 | 106 |
| 2012 | 3 | 111 | 0 | 337 |
| 2013 | 1 | — | 0 | 140 |
| 2014 | 1 | — | 0 | 105 |
| 2015 | 0 | — | 0 | 110 |
| 2016 | 1 | — | 0 | 135 |
| 2017 | 1 | — | 0 | 74 |
| 2018 | 2 | — | 0 | 42 |
| 2019 | 4 | 84 | 0 | 35 |
| 2020 | 0 | — | 0 | 32 |
| 2021 | 2 | — | 0 | 31 |
| 2022 | 1 | — | 0 | 16 |
| 2023 | 2 | — | 0 | 9 |
| 2024 | 0 | — | 0 | 8 |
| 2025 | 0 | — | 0 | 9 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
MedSCl 3% glutaraldehyde may be used to sterilize or high-level disinfect reusable medical devices that are heat labile or otherwise incompatible with other biologically monitored methods of sterilization. MedSCi 3% glutaraldehyde is intended to be used by healthcare practitioners, e.g., doctors, nurses and dentists in various healthcare facilities, e.g., hospitals, doctors offices and dentist offices. Germicidal Level of Activity of MedSCl 3%…
Read the full statement (174 words)
MedSCl 3% glutaraldehyde may be used to sterilize or high-level disinfect reusable medical devices that are heat labile or otherwise incompatible with other biologically monitored methods of sterilization. MedSCi 3% glutaraldehyde is intended to be used by healthcare practitioners, e.g., doctors, nurses and dentists in various healthcare facilities, e.g., hospitals, doctors offices and dentist offices.
Germicidal Level of Activity of MedSCl 3% glutaraldehyde as a:
Staerilant. MedSCl 3% glutaraldehyde is a sterilant when reusable medical devices are immersed for 10 hours at 25°C. It may be used or reused for a maximum of 28 days if the glutaraldehyde concentration is above the Minimum Effective Concentration (MEC) of 1.8% as determined by the 3M Cold Sterilog® 2.1% Glutaraldehyde Monitor.
High-Level Disinfectant. MedSCl 3% glutaraldehyde is a high-level disinfectant when reusable medical devices are immersed for 25 minutes at 25° C. It may be used or reused for a maximum of 28 days if the glutaraldehyde concentration is above the Minimum Effective Concentration (MEC) of 1.8% as determined by the 3M Cold Sterilog® 2.1% Glutaraldehyde Monitor.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K974062 · printed Nov 4, 2026
Cite this page
510(k) Report. “K974062: Medsci 3% Glutaraldehyde.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K974062
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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