510(k) · Cleared

Cleared

Naturalyte Bicarbonate Concentrate-Dry Pack

K852310510(k) TraditionalCleared Jul 26, 198558-day reviewClass II21 CFR 876.5820

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

Erika, Inc. · FKQ System, Dialysate Delivery, Central Multiple Patient

Cleared on Jul 26, 1985 after a 58-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it.

Decided: Jul 26, 1985
Review: 58 days
Class: Class II
Product code: FKQ
Recalls: None
Predicates: 0

1 later device descends from it, 1 citing it directly.

This deviceK852310 Naturalyte Bicarbonate Concentrate-Dry PackErika, Inc. · 1985
Descendant · cites it directly · 0 of its ownK070177 Fresenius Naturalyte Liquid Acid Concentrate, 9000, 6000 and 4000…Fresenius Medical Care North America · 2007 · Recalled

Most influential descendants

Showing 1 of 1 · See all

K070177Fresenius Naturalyte Liquid Acid Concentrate, 9000, 6000 and 4000 SeriesFresenius Medical Care North America · 2007 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K852310	Naturalyte Bicarbonate Concentrate-Dry Pack	Erika, Inc.	1985	—
+1	K070177	Fresenius Naturalyte Liquid Acid Concentrate, 9000, 6000 and 4000 Series	Fresenius Medical Care North America	2007	35

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2007	1	0

FIG. 1 — Lineage of K852310, 1985–2007Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 FKQ? 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? (1)

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

Number	Device	Applicant	Decided	Descendants
K070177	Fresenius Naturalyte Liquid Acid Concentrate, 9000, 6000 and 4000 Series	Fresenius Medical Care North America	2007	0

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, K070177 (Fresenius Medical Care North America, 2007) has gone furthest, with 0 descendants of its own.

How does its category compare?

All FKQ devices

FKQ System, Dialysate Delivery, Central Multiple Patient: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FKQ

FDA has decided no FKQ device since 2007.

Median 510(k) review, days · FKQ

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

Recalls per year · FKQ

No recall names FKQ since 2007.

Adverse event reports per year · FKQ

6in 2024

2007high 6 (2024) · low 0 (2007)2025

MAUDE reports naming product code FKQ, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Median 510(k) review, days	MAUDE reports
2007	—	0
2008	—	0
2009	—	0
2010	—	1
2011	—	0
2012	—	0
2013	—	0
2014	—	0
2015	—	0
2016	—	0
2017	—	1
2018	—	0
2019	—	1
2020	—	0
2021	—	2
2022	—	0
2023	—	3
2024	—	6
2025	—	0
2026	—	—

https://510kreport.com/device/K852310 · printed Nov 5, 2026

Cite this page

510(k) Report. “K852310: Naturalyte Bicarbonate Concentrate-Dry Pack.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K852310

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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