510(k) · Cleared

Cleared

Redyrob-Closed Wound Drainage System

K972703510(k) TraditionalCleared Oct 1, 199775-day reviewClass I21 CFR 878.4680

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

B.Braun Medical, Inc. · GCY Apparatus, Suction, Single Patient Use, Portable, Nonpowered

Cleared on Oct 1, 1997 as substantially equivalent to K883582 (Surgidyne, Inc., 1988) after a 75-day review. Its family tree reaches back 1 generation to 1988. 4 later devices descend from it.

Decided: Oct 1, 1997
Review: 75 days
Class: Class I
Product code: GCY
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K883582 (1988). 4 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK883582 Varidyne Model 250 Suction Drainage SystemSurgidyne, Inc. · 1988
This deviceK972703 Redyrob-Closed Wound Drainage SystemB.Braun Medical, Inc. · 1997
Descendant · cites it directly · 3 of its ownK180606 SOMAVAC DeviceSomavac Medical Solutions, Inc. · 2018
Descendant · 2 generations on · 2 of its ownK222856 SOMAVAC 100 Sustained Vacuum SystemSomavac Medical Solutions, Inc. · 2022
Descendant · 3 generations on · 0 of its ownK231063 SOMAVAC® 100 Sustained Vacuum SystemSomavac Medical Solutions, Inc. · 2023
Descendant · 3 generations on · 0 of its ownK223373 Enivo™Aroa Biosurgery, Ltd. · 2023

Most influential descendants

Showing 4 of 4 · See all

K180606SOMAVAC DeviceSomavac Medical Solutions, Inc. · 2018 · cites it directly3descendants
K222856SOMAVAC 100 Sustained Vacuum SystemSomavac Medical Solutions, Inc. · 2022 · 2 generations on2descendants
K231063SOMAVAC® 100 Sustained Vacuum SystemSomavac Medical Solutions, Inc. · 2023 · 3 generations on0descendants
K223373Enivo™Aroa Biosurgery, Ltd. · 2023 · 3 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K883582	Varidyne Model 250 Suction Drainage System	Surgidyne, Inc.	1988	—
0 (this device)	K972703	Redyrob-Closed Wound Drainage System	B.Braun Medical, Inc.	1997	—
+1	K180606	SOMAVAC Device	Somavac Medical Solutions, Inc.	2018	—
+2	K222856	SOMAVAC 100 Sustained Vacuum System	Somavac Medical Solutions, Inc.	2022	—
+3	K231063	SOMAVAC® 100 Sustained Vacuum System	Somavac Medical Solutions, Inc.	2023	—
+3	K223373	Enivo™	Aroa Biosurgery, Ltd.	2023	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2018	1	0
2022	1	0
2023	2	0

FIG. 1 — Lineage of K972703, 1988–2023Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 GCY? 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? (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	Applicant	Decided	Recalls
*	K883582	Varidyne Model 250 Suction Drainage System Summary page 1 …, Nonpowered Classification name: General Hospital and Plastic Surgery Class:,79 GCY 21 CRF 878.4680 SUBSTANTIAL EQUIVALENCE! TO: Applicant. - 510(k) number ~ [Name K883582 Varidyne Model 250 Suction Surgidyne Drainage System Device Description: in accordance with section 510(k) for the Federal Food…	Surgidyne, Inc.	1988	—

What descends from it? (4)

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

Number	Device	Applicant	Decided	Descendants
K180606	SOMAVAC Device	Somavac Medical Solutions, Inc.	2018	3

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.
Of its descendants, K180606 (Somavac Medical Solutions, Inc., 2018) has gone furthest, with 3 descendants of its own.

How does its category compare?

All GCY devices

GCY Apparatus, Suction, Single Patient Use, Portable, Nonpowered: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GCY

FDA has decided no GCY device since 2007.

Median 510(k) review, days · GCY

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

Recalls per year · GCY

1in 2018

2007high 38 (2008) · low 0 (2007)2026

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

Adverse event reports per year · GCY

178in 2025

2007high 260 (2017) · low 47 (2012)2025

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

View these four charts as a table

Year	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	—	0	246
2008	—	38	205
2009	—	2	231
2010	—	1	124
2011	—	12	58
2012	—	0	47
2013	—	0	70
2014	—	0	95
2015	—	0	93
2016	—	0	145
2017	—	0	260
2018	—	1	180
2019	—	0	200
2020	—	0	202
2021	—	0	216
2022	—	0	96
2023	—	0	90
2024	—	0	74
2025	—	0	178
2026	—	0	—

What is it indicated for?

REDYROB® is a vacuum source/waste container utilized for postoperative wound drainage.

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/K972703 · printed Nov 6, 2026

Cite this page

510(k) Report. “K972703: Redyrob-Closed Wound Drainage System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K972703

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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