Span-America Medical Systems, Inc.: FDA filings under this applicant name
FDA lists 19 510(k) clearances under the applicant name “Span-America Medical Systems, Inc.” (first 1980, latest 1998), across 7 product codes in 3 review panels. Median 510(k) review time under this name: 88 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FNM | Mattress, Air Flotation, Alternating Pressure | 8 | 8 |
| KMJ | Lubricant, Patient | 3 | 3 |
| LKB | Pad, Alcohol, Device Disinfectant | 3 | 3 |
| KIC | Cushion, Flotation | 2 | 2 |
| FMF | Syringe, Piston | 1 | 1 |
| HKX | Tonometer, Ac-Powered | 1 | 1 |
| IKZ | Bed, Patient Rotation, Powered | 1 | 1 |
Review panels
- General Hospital (15)
- Physical Medicine (3)
- Ophthalmic (1)
Most recent Span-America Medical Systems, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K973169 | PRESSURE GUARD SITE SELECT (A) | FNM | 1998-02-20 | 179 |
| K972486 | PRESSUREGUARD IV | IKZ | 1998-02-20 | 233 |
| K960188 | PRESSUREGUARD: SELECTCARE | FNM | 1996-10-02 | 260 |
| K961502 | LUBRICATING JELLY, LOW VISCOSITY | KMJ | 1996-07-18 | 90 |
| K961159 | POWERED LOW AIR LOSS MATTRESS SYSTEM | FNM | 1996-06-14 | 84 |
| K960620 | PRESSUREGUARD: LOW AIR LOSS MATTRESS SYSTEM | FNM | 1996-04-25 | 72 |
| K960189 | GEL-T CUSHION | KIC | 1996-02-07 | 22 |
| K954766 | PRESSURE GUARD ALTERNATING PRESSURE MATTRESS | FNM | 1996-01-11 | 86 |
| K953503 | PRESSUREGUARD IV | FNM | 1995-10-24 | 90 |
| K954117 | CUSTOMCARE SEATING SYSTEM | KIC | 1995-10-13 | 42 |
9 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Span-America Medical Systems, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Span-America Medical Systems, Inc.?
FDA lists 19 510(k) clearances under the applicant name “Span-America Medical Systems, Inc.” (first 1980, latest 1998), across 7 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Span-America Medical Systems, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Span-America Medical Systems, Inc. is 88 days.
Which FDA product codes appear under Span-America Medical Systems, Inc.?
The most frequent FDA product codes under this applicant name are FNM (Mattress, Air Flotation, Alternating Pressure, 8); KMJ (Lubricant, Patient, 3); LKB (Pad, Alcohol, Device Disinfectant, 3).
Next steps
- See all 19 Span-America Medical Systems, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FNM, Span-America Medical Systems, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.