510(k) Report

510(k) · Cleared

Cleared

D-PBS, Products NO. D5652

K851606510(k) TraditionalCleared May 15, 198529-day reviewClass I21 CFR 864.2220

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

Sigma Chemical Co. · KIT Media And Components, Synthetic Cell And Tissue Culture

Cleared on May 15, 1985 after a 29-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.

Decided
May 15, 1985
Review
29 days
Class
Class I
Product code
KIT
Recalls
None
Predicates
0

3 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2010: 1 descendant cleared2023: 1 descendant cleared2022: 1 descendant cleared1990200020102020
  1. This deviceK851606 D-PBS, Products NO. D5652Sigma Chemical Co. · 1985
  2. Descendant · cites it directly · 2 of its ownK102867 Iroot FSInnovative Bioceramix, Inc. · 2010
  3. Descendant · 2 generations on · 0 of its ownK213757 Endocem MTA Premixed RegularMaruchi · 2023
  4. Descendant · 2 generations on · 0 of its ownK222992 iRoot BP Root Repair Material BioAggregate Paste;iRoot FS Fast Set…Innovative Bioceramix, Inc. · 2022

Most influential descendants

Showing 3 of 3 · See all
  • K102867Iroot FSInnovative Bioceramix, Inc. · 2010 · cites it directly2descendants
  • K213757Endocem MTA Premixed RegularMaruchi · 2023 · 2 generations on0descendants
  • K222992iRoot BP Root Repair Material BioAggregate Paste;iRoot FS Fast Set Root Repair Material…Innovative Bioceramix, Inc. · 2022 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K851606D-PBS, Products NO. D5652Sigma Chemical Co.1985—
+1K102867Iroot FSInnovative Bioceramix, Inc.2010—
+2K213757Endocem MTA Premixed RegularMaruchi2023—
+2K222992iRoot BP Root Repair Material BioAggregate Paste;iRoot FS Fast Set Root Repair…Innovative Bioceramix, Inc.2022—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201010
202210
202310
FIG. 1 — Lineage of K851606, 1985–2023Source: 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 KIT? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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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? (3)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K102867Iroot FSInnovative Bioceramix, Inc.20102

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?

  • Of its descendants, K102867 (Innovative Bioceramix, Inc., 2010) has gone furthest, with 2 descendants of its own.

How does its category compare?

All KIT devices

KIT Media And Components, Synthetic Cell And Tissue Culture: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KIT

FDA has decided no KIT device since 2007.

Median 510(k) review, days · KIT

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

Recalls per year · KIT

4in 2018

2018: 4
2007high 4 (2018) · low 0 (2007)2026

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

Adverse event reports per year · KIT

1in 2020

2010: 12020: 1
2007high 1 (2010) · low 0 (2007)2025

MAUDE reports naming product code KIT, 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
20070—00
20080—00
20090—00
20100—01
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—40
20190—00
20200—01
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

More from Sigma Chemical Co.

231 FDA decisions under this applicant name. See the company

  • K933694Sigma Glucose ReagentSigma Chemical Co. · 1994
  • K933678Sigma Calcium ReagentSigma Chemical Co. · 1994
  • K933696Sigma Electrolyte Reference ReagentSigma Chemical Co. · 1994
  • K933691Sigma CO2 Alkaline Buffer ReagentSigma Chemical Co. · 1993
  • K933679Sigma Bun ReagentSigma Chemical Co. · 1993

Recent decisions in KIT

The KIT category page

  • K892938Amnio-Grow TMInovar Biologicals, Inc. · 1989
  • K890701Endothelial Growth Medium (Egm)Clonetics Corp. · 1989
  • K890700Melanocyte Growth Medium (MGM)Clonetics Corp. · 1989
  • K890482Abc, Abc-1X, Abc (TM)Cell Ent., Inc. · 1989
  • K884654Alphacalf SerumHyclone Laboratories, Inc. · 1988

https://510kreport.com/device/K851606 · printed Nov 6, 2026

Cite this page

510(k) Report. “K851606: D-PBS, Products NO. D5652.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K851606

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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